MULTI-TRAUMA DRESSING

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

GAM INDUSTRIES, INC.

The following data is part of a premarket notification filed by Gam Industries, Inc. with the FDA for Multi-trauma Dressing.

Pre-market Notification Details

Device IDK925590
510k NumberK925590
Device Name:MULTI-TRAUMA DRESSING
ClassificationGauze, External (with Drug/biologic/animal Source Material)
Applicant GAM INDUSTRIES, INC. P.O. BOX 2226 Petersburg,  VA  23804 -1526
ContactGary J Beden
CorrespondentGary J Beden
GAM INDUSTRIES, INC. P.O. BOX 2226 Petersburg,  VA  23804 -1526
Product CodeGER  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-11-05
Decision Date1993-04-08

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