All American 25x User manual
Your Sterilizer Experts
Manufacturing –Distribution –Maintenance- Guaranteed!
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1807.81 1807.87
act,
or
because
the
COmmissioner
has
found,
under
section
510(g')(4)
of
the
act,
that
such
reg1stra.tion
is
not
nec-
easa.ry
for
the
protection
of
the
public
health:
(a) A
manufacturer
of
raw
mater1a.ls
or
components
to
be used
in
the
manu-
facture
or
assembly
of
a device who
would
otherwise
not
be
required
to
reg'-
ister
under
the
provisions
of
this
part.
(b)
A manut'a.cturer
of
devices
to
be
used solely for veter1na.ry purposes.
(c) A manut'a.cturer
of
general
pur-
pose
articles
such
as
ohemtoa.l
reagents
or
laboratory
equipment
whose uses
are
generally
known
by persons
trained
in
their
use
and
whioh
are
not
labeled
or
promoted
for medioa.l uses.
(d) Licensed
practitioners,
includinS'
Physic1a.ns,
dentists,
and
optometrists,
who
manufacture
or
otherwise
alter
de-
vioes solely
for
use
in
their
practice.
(e) Pha.rma.cies, sur8'1oa.l supply
out-
lets,
or
other
s1m11a.r
reta.11
establish-
ments
making'
f1naJ.
delivery
or
we
to
the
ultimate
user.
This
exemption a.lso
applies
to
a pha.rma.oy
or
other
s1m1la.r
retail
establishment
that
purchases a
device
for
subsequent
distribution
under
its
own
name,
e.g'., a properly
la-
beled
health
aid
such
as
an
elastic
ban-
dage
or
crutch,
indicatinB'
"distributed
by"
or
"manufactured
for"
followed by
the
name
of
the
pha.rmacy.
(£)
Persons
who
manufacture,
pre-
PIL1'8,
propagate. compound,
or
process
devices
solely
for
use
in
research.
teachinB',
or
analysis
and
do
not
intro-
duce
such
devices
into
commeroia.l
dis-
tribution.
(g')
[Reserved1
(h)
Carriers
by
reason
of
their
re-
ceipt,
carriage,
hoIdinS'
or
delivery
of
devices
in
the
usUal course
of
bUSiness
as
oa.rriers.
(i) Persons who dispense devices
to
the
ultimate
consumer
or
whose
major
responsibility
is
to
render
a service
neceasa.ry
to
provide
the
consumer (i.e.,
patient.
physician,
la.yma.n.
eto.)
with
a
device
or
the
benefits
to
be derived
from
the
use
of
a devioe; for example, a
hea.r1ng'
aid
dispenser. optiCian, clinioa.l
laboratory.
assembler
of
dia.B'nostic x-
ray
systemll,
and
personnel
from a hos-
pital,
olinic.
dental
laboratory.
orthotic
or
prosthetic
retail
facUity,
whose
pr1ma.r:y
responstbWty
to
the
ul-
timate
consumer
is
to
dispense
or
pro-
21
en
Ch. I (4-1-95 EdItIon)
vide a service throUB'h
the
use
of
a
pre-
viously manufactured device.
[42
FR
42526,
Aug.
lIS.
19'1'7.
as amended
at
68
FR
46523,
Sept.
1,
1998]
Subpart
E-Premarket
Notification
Procedures
1807.81 When a preIIIIU'kef; DOtiflcatioJl
nb..u..ton
..
required.
(a) Except as provided
in
paragraph
(b)
of
this
seotion,
each
person who
is
required
to
repter
his
establishment
pursuant
to
180'7.20
must
submit
a
pre-
ma.rket not111cat1on submission
to
the
Food
and
Dru&'
Administration
at
least
90
da.:vB
before he proposes
to
beB'1n
the
introduction
or
delivery for introduc-
tion
into
interstate
commerce for com-
mero1al
distribution
of a device, in-
tsnded
for
human
use which
meets
any
of
the
follow1nB'
criteria:
(1)
The
device
is
be1nB'
introduced
into
commeroial distribution for
the
first
time;
that
is,
the
device
is
not
of
the
same
type
as,
or
is
not
subatan-
tia.lly equivalent
to"
(i) a device
in
commeroia.l
distribution
before
May
28,
19'16,
or
(11)
a device introduced for
oommeroia.l
distribution
a.fter
May
28,
1976.
that
has
subsequently been
reo1a.s-
sified
into
class I
or
n.
(2)
The
device is
be1nB'
introduced
into
oommeroia.l
distribution
for
the
first
time
by
a person required
to
reg'-
ister,
whether
or
not
the
device
meets
the
criteria
in
pa,rag-raph (a)(I)
of
this
seotion.
(S)
The
device
is
one
that
the
person
currently
has
in
commercia.l distribu-
tion
or
is
reintroduoing'
into
commer-
cial
diStribution,
but
that
is
about
to
be BiB'nificantly ohanged
or
modifled
in
desiB'n. oomponents, method
of
manu-
facture,
or
intended use. The
follow1DB'
constitute
BiB'nifica.nt
cha.ng'es
or
modi-
fications
that
require a prema.rket no-
tification:
(i) A
cha.Dg'e
or
modification
in
the
device
that
co1ild BiB'nificantly a.tIect
the
sa.fety
or
effectiveness
of
the
de-
vice, e.g'., a BiB'nifica.nt
ohanB'e
or
modi-
fication
in
des1p,
mater1a.l, chemica.l
oomposition, energy source,
or
manu-
facturing' process.
(11)
A
major
cha.Dg'e
or
modiflcation
in
the
intended
use
of
the
device.
(b) A prema.rket notification under
this
subpart
is
not
required for a device
Food and
Drug
AcImInIItraIIon.
HHS
for which a prema.rket approval appli-
cation
under section
515
of
the
act.
or
for which a petition
to
reclass1ty under
. section
518(£)(2)
of
the
act.
is
pendinS'
before
the
Food
and
Drag
Administra-
tion.
(c)
In
addition
to
comPl:v1nB'
with
the
requirements
of
this
part,
owners
or
operators
of
device
establishments
that
manufacture radtation-emttting' elec-
tronio products, as defined
in
§1000,S
of
this
chapter, sha.ll oomply
with
the
re-
porting'
requirements
of
Part
1002
of
this
oha.pter.
180'7.81
Blremptlon
from.
pnmarket
DOtHlcatiOll.
(a) A devioe
is
exempt from
the
pre-
ma.rket notification
requirements
of
this
subpart
if
the
device intended for
introduotion
into
oommeroial distribu-
tion
is
not
generally availa.ble
in
fin-
ished form for purchase
and
is
not
of-
fered
throUB'h
labellDB'
or
advertis1Dg'
by
the
manufacturer, Importer,
or
dis-
tributor
thereof for commeroiaJ, dis-
tribution,
and
the
device
meets
one
of
the
following' conditions:
(1)
It
is
intended for use
by
a
patient
named
in
the
order
of
the' phys101s.D
or
dentist
(or
other
specia.lly quaJ.tfied
person);
or
(2)
It
is
intended solely for use
by
a
physio1an
or
dentist
(or
other
specia.lly
quaJ.tfied person)
and
is
not
genera.lly
availa.ble to,
or
generally used by,
other
physio1a.ns
or
dentists
(or
other
specially qua.l1fied persons).
(b)
A
distributor
who places a device
into
oommero1al
distribution
for
the
first
time
under
his
own
name
and
a
repa.okager who places
his
own
name
on
a devioe
and
does
not
oha.Dg'e
any
other
labellDB'
or
otherwise a.tIeot
the
device shall be exempted from
the
pre-
ma.rket notification
requirements
of
this
subpart
if:
(1)
The device was
in
commeroia.l dis-
tribution
before
May
28.
19'16;
or
(2)
A prema.rket
notification
submis-
sionwas
rued
by
another
person.
1807.87 IDfonaatioJl
reqalrecllD
a
pre-
IIl8I'Ut
DOW'ieatioD
Inibm_lou.
Each prema.rket
notification
submis-
sion sha.ll
contain
the
followiDB'
infor-
mation:
(a) The device name, inclUding'
both
the
trade
or
proprietary
name
and
the
common
or
usual
name
or
classifica-
tion
name
of
the
device.
(b)
The establ1shment r8B'istration
number.
if
applicable,
of
the
owner
or
operator
submttt1nB'
the
prema.rket no-
tification
submtssion.
(c)
The
class
in
whioh
the
devioe
has
been
put
under
section
513
of
the
'act
and.
if
known.
its
appropriate
panel;
or,
if
the
owner
or
operator
determines
that
the
device
has
not
been classified
under
such
section. a
statement
of
that
determination
and
the
basis
for
the
person's
determination
that
the
device
Is
not
so classified.
(d) Action
taken
by
the
person
re-
quired
to
reB'ister
to
comply
with
the
requirements
of
the
act
under
section
514
for performance sta.nda.rdB.
(e) Proposed labels, label1nB',
and
ad-
vertisements
sufficient
to
describe
the
device,
its
intended
use.
and
the
direc-
tions
for
its
use. Where applicable. pho-
tog'raphs
or
enB'ineering' drawing'S
should be supplied.
(£)
A
statement
indicating'
the
devioe
is
s1m11a.r
to
and/or
different
from
other
products
of
compa.rable
o/.P8
in
commeroial
distribution.
accompanied
by
data
to
support
the
statement.
This
information
may
include
an
identifica-
tion
of
s1m11a.r
produots,
materials.
de-
Sip
oonsiderations,
enerB'Y
expected
to
be used
or
delivered
by
the
device,
and
a description
of
the
operational
prin-
oiples
of
the
device.
(g')
Where a person
required
to
reg'-
ister
intends
to
introduce
into
oom-
meroia.l
distribution
a device
that
has
underg'one a sign1f1cant
cha.Dg'e
or
modification
that
could
sipifioantly
affect
the
sa.fety
or
effectiveness
of
the
device,
or
the
device
is
to
be ma.rketed
for a new
or
different
indication
for
use,
the
prema.rket
notification
sub-
mission
must
include
appropriate
sup-
port1nB'
data
to
show
that
the
manufac-
turer
has considered
what
con-
sequences
and
effects
the
ohang'e
or
modification
or
new use mtg'ht
have
on
the
sa.fety
and
effectiveness
of
the
de-
vice.
(h)
A
61O(k)
summary
as
described
in
§807.92
or
a 510(k)
statement
as
de-
scr1bed
in
180'7.98.
(1)
For
submiSSiOns ola.1m1ng'subeta.n-
tial
equivalence
to
a device which
has
been classified
into
olass m
under
sec-
tion
513(b)
of
the
act:
ALL
-
AMERICA'N"
}>ortable
"
STEAM
PRESSURE
Sterilizer
eAST
AWMfNUM DUll
GAUOE
AN.
CONlitltllCTION VAl'll! COfCTllOl
STAMI'D
ALUMINUM
MEI'AL
TO
M8Al
SIAL
SEAMU!SS
INS"
CONTAINEJ,
(No
avWNr Co-':ofIJ
WY
TO
ClEAH
lAAOI
C::AS1'
ALUMINUM
STIIU...
Z'''.
CAPAClI'Y
ClLAlI
lAC(
COMJ'L&1I
AND
i"liCTlVe
flUlttl
MlfA\.
EXHAUST
S'IUIUZAnOH
AT
THI
lUle
.. l.OWl!tl
posS/allco"
ALL-AMERICAN
Sterilizers
mak.
it
pouibl.
{or
aU
doctor..
dentiats,.
fint
aid
stations, ho."Pitallt
and
1aboratori~.
to
have
fool-ptoOf aterllization facilities
at
an
extremely
low
cost.
Used
over
a1'ly
effective:
heet
source,
it
ia
only
a
matter
of
minutes
to
secure
dry
sterile
dr_np
and
instrum6"'ts, with all bacteria
and mic:ro-orranlsms destroyed. Only a
small
amount
of
water
is
Deeded.
and
the
dry
.tttam
at
20
lbt.
pressure
penetrates
all binges
aod
crevasses
i~
any
instrument
and
makes
them
sterile
in
15
to
20
minutu.
Nc.
wiping
is
nec_
..
ry
to
remove
chemical
residue
or
moisture,
'IUld
cutting
edges
are
n01
dulled.
Dressings
191'e
made
stlM"ile
in
about 30 minutes, and
ready
lor Immediat¢' use.
THREE
POPULAR
SIZES:
N
••
It)U~-)(
(15% qt. liquid cap.),
SIMp.
Wt.
20
u.t,
No. 1925-X (25
qt.
hquld "ap.), Ship. Wt.
25
•••
No,
1941~.X
(4Ht
qt.
liquid I:1Ip.),
Ship.
Wt.
39
I".
Each
...
~u'--
peclnrcl
I.
indl"hb
••
l COn'\l9111ec1 c:adl>U.
Th.
AJ.I....AMERICAN Stllrill.:ers
<liT€!
math:
oi
hiah QUAlity
<:$81
aluminum
alloy. with
.n
the
ap~eial
CeatUres
or
the
famous
ALL-AMERICAN
PreSlllr~
C:»okers.
The
meblJ..to-mllllt.al
seal
elimina.tes all rub-
ber
lasleets, and 1he ciampina lQCks
prevent
rvmoval
01
the
cover
while
thlllll"Q
Is
p1"lot$Suce
pN$enl:,
af!
a
safety feature. An accurate
prl!'ssuca:
Raup,
tilt~
fOI
easy
I"eadinc.
pr4lSSut~
conte-oJ
valve
and
oVI!T-pres·
sure
$.Qfety plug.
metal
air
",lease
tUbing
for qukl(
exhawst.ioR
of
all air
within
th~
Sterilj,:«r.
and
cool
bakelite
nandle
and
winK
nut.51
nee
aU
thoroulI-hlJ.·
tested
features
that
assurft
¥.'lte,
fool-proof
orx:ratior..
with
a
minimum
amount
of
attentiun,
••
Please email
or
call for any additional information you
..
may
need: [email protected] 1(800)762-1586
--
6054
2157
/
,
~'-
...
-
_._-....,.
"'
.......
_
..
""
.
"--'
ALe
-Ar1ER
H~1~N
SI
E1IT[TZERS
__
___
-
..
-
.......
-
JOBBERS
PRICE
LIST
-EFFECTIVE
APRIL
(S,
1976
.~
ITEM
OEseR
I
PTt
ON
STO~NQ"
...
-"
.'
..
CAST
ST£RILIZER
1St
qt.
lJquTd cap_
UN
IT
PR
iCE
.
~
.3~
...
25
RECOMMENDED
RETA
IL
PRICE
.
"$
-05
....
90 - .
. .
I ,
..
'
CAST
STER
ft.
rZER
25
qt.
irqutd
cap.
42.85 1 77.90
··19.2SX·
-<"""'"
UN
tT
~.s."'tFfI
NG
PACK.
~.WEIGl-tT
20
1bs.
25
Tbs.
CAST
STER!UZER
•
f
41!
qt.
liqufd
cap.
r
I 79
.•
15 1 143
..
90 ,
f
42
lbs
..
t
,
25x-.rOV
t
ELECTRIC
STEROCLAVE
I
f I
110
VOLTS
j
831 Cubic Inches Cap. 103
..
95,
.
f89.00
r
30
lbs,.
I
,
2SX-2.2.0V
!
NSTALlATI
ON
OF
6054
ELECTRIC
STEROCLAVE
220
VOLTS
831 Cubic
lnenes
Cap.
THERMOMETER
Stainless
Steel
50
0 -
300
0
THERMOMETER
rNSTALlED AT
FACTORY
GROUNDED
3
WIRE
ELE"CTR
IC
CORD
AND
PLUG
107.25
rO.95
,
8.80
4.35
i
I 195
..
00
19.90
16.00
7
..
90
I
SO
.1bs
..
I
12
oz,.
r
I
14
OZ
.•
FREIGHT
TERMS:
F.O.B.
F'ACTORY
rN
ANY
QUANTlTY.
PRICES
SUBJECT
TO
CHANGE
WITHOUT
NOTfCEp
Please note
that
above prices
are
from 1976 and are only for
demonstration purposes. Please email orcall for any additional
information you may need: [email protected] 1-(800)762-1586
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