STERIGAGE EO 100%

Indicator, Physical/chemical Sterilization Process

PYMAH CORP.

The following data is part of a premarket notification filed by Pymah Corp. with the FDA for Sterigage Eo 100%.

Pre-market Notification Details

Device IDK934874
510k NumberK934874
Device Name:STERIGAGE EO 100%
ClassificationIndicator, Physical/chemical Sterilization Process
Applicant PYMAH CORP. 89 ROUTE 206 PO BOX 1114 Somerville,  NJ  08876
ContactBernard Konopko, R.ph., P.d.
CorrespondentBernard Konopko, R.ph., P.d.
PYMAH CORP. 89 ROUTE 206 PO BOX 1114 Somerville,  NJ  08876
Product CodeJOJ  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-10-12
Decision Date1995-04-18

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