ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION

Indicator, Physical/chemical Sterilization Process

PYMAH CORP.

The following data is part of a premarket notification filed by Pymah Corp. with the FDA for Ati Disposable Test Pack For Steam Sterilization.

Pre-market Notification Details

Device IDK952408
510k NumberK952408
Device Name:ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION
ClassificationIndicator, Physical/chemical Sterilization Process
Applicant PYMAH CORP. 8904 PADDOCK LN. Potomac,  MD  20854
ContactBernard Konopko
CorrespondentBernard Konopko
PYMAH CORP. 8904 PADDOCK LN. Potomac,  MD  20854
Product CodeJOJ  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-22
Decision Date1995-07-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50707387236477 K952408 000
50707387236453 K952408 000

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