DERMAGRAN WOUND DRESSING

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

DERMA SCIENCES, INC.

The following data is part of a premarket notification filed by Derma Sciences, Inc. with the FDA for Dermagran Wound Dressing.

Pre-market Notification Details

Device IDK924754
510k NumberK924754
Device Name:DERMAGRAN WOUND DRESSING
ClassificationGauze, External (with Drug/biologic/animal Source Material)
Applicant DERMA SCIENCES, INC. 121 WEST GRACE ST. Old Forge,  PA  18518
ContactMary G Clark
CorrespondentMary G Clark
DERMA SCIENCES, INC. 121 WEST GRACE ST. Old Forge,  PA  18518
Product CodeGER  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-09-23
Decision Date1993-05-27

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