STERIGAGE INTEGRATOR TEST PACK FOR STEAM STERILI.

Indicator, Biological Sterilization Process

PYMAH CORP.

The following data is part of a premarket notification filed by Pymah Corp. with the FDA for Sterigage Integrator Test Pack For Steam Sterili..

Pre-market Notification Details

Device IDK894399
510k NumberK894399
Device Name:STERIGAGE INTEGRATOR TEST PACK FOR STEAM STERILI.
ClassificationIndicator, Biological Sterilization Process
Applicant PYMAH CORP. 89 ROUTE 206 PO BOX 1114 Somerville,  NJ  08876
ContactRoberta Parmelee
CorrespondentRoberta Parmelee
PYMAH CORP. 89 ROUTE 206 PO BOX 1114 Somerville,  NJ  08876
Product CodeFRC  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-17
Decision Date1989-09-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50707387469172 K894399 000

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