FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

ATI DISPOSABLE BIOLOGICAL TEST PACK FOR STEAM STER

K Number: K902344 · Decision Jul 19, 1990
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
205
Applicant Total
3
Review Days
55

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Basic Information

Device Name
ATI DISPOSABLE BIOLOGICAL TEST PACK FOR STEAM STER
K Number
K902344
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.2800
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Ati
Date Received
May 25, 1990
Decision Date
July 19, 1990
Product Code
FRC
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
FRC Indicator, Biological Sterilization Process

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Other Clearances by Ati

K Number Device Name
K890853 AQUA-PAD FOR MOIST OR DRY HEAT THERAPY
K890852 AQUA-BLANKET HYPER/HYPOHERMIA BLANKET