DERMAGRAN WET DRESSING (ZINC-SALINE)

Dressing, Wound And Burn, Occlusive

DERMA SCIENCES, INC.

The following data is part of a premarket notification filed by Derma Sciences, Inc. with the FDA for Dermagran Wet Dressing (zinc-saline).

Pre-market Notification Details

Device IDK954742
510k NumberK954742
Device Name:DERMAGRAN WET DRESSING (ZINC-SALINE)
ClassificationDressing, Wound And Burn, Occlusive
Applicant DERMA SCIENCES, INC. 121 WEST GRACE ST. Old Forge,  PA  18518
ContactHoward Enfiejian
CorrespondentHoward Enfiejian
DERMA SCIENCES, INC. 121 WEST GRACE ST. Old Forge,  PA  18518
Product CodeMGP  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-10-16
Decision Date1995-11-02

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