GERITREX STERILE SALINE WET DRESSING

Gauze, External (with Drug/biologic/animal Source Material)

GERITREX CORP.

The following data is part of a premarket notification filed by Geritrex Corp. with the FDA for Geritrex Sterile Saline Wet Dressing.

Pre-market Notification Details

Device IDK931510
510k NumberK931510
Device Name:GERITREX STERILE SALINE WET DRESSING
ClassificationGauze, External (with Drug/biologic/animal Source Material)
Applicant GERITREX CORP. 2 EAST SANFORD BLVD. Mount Vernon,  NY  10550 -4510
ContactAnthony Madaio
CorrespondentAnthony Madaio
GERITREX CORP. 2 EAST SANFORD BLVD. Mount Vernon,  NY  10550 -4510
Product CodeGER  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-26
Decision Date1993-07-13

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