DISPOSABLE STEAM BIOLOGICAL TEST PACK

Indicator, Biological Sterilization Process

PARKE-DAVIS CO.

The following data is part of a premarket notification filed by Parke-davis Co. with the FDA for Disposable Steam Biological Test Pack.

Pre-market Notification Details

Device IDK852192
510k NumberK852192
Device Name:DISPOSABLE STEAM BIOLOGICAL TEST PACK
ClassificationIndicator, Biological Sterilization Process
Applicant PARKE-DAVIS CO. 870 PARKDALE RD. Rochester,  MI  48307
ContactEdward F Cleary
CorrespondentEdward F Cleary
PARKE-DAVIS CO. 870 PARKDALE RD. Rochester,  MI  48307
Product CodeFRC  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-05-20
Decision Date1985-11-01

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