DERMAGRAN WOUND DRESSING

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 Wound Dressing.

Pre-market Notification Details

Device IDK954740
510k NumberK954740
Device Name:DERMAGRAN WOUND DRESSING
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.