DERMATEC TRANSPARENT FILM DRESSING

Dressing, Wound, Drug

DERMATEC, INC.

The following data is part of a premarket notification filed by Dermatec, Inc. with the FDA for Dermatec Transparent Film Dressing.

Pre-market Notification Details

Device IDK863580
510k NumberK863580
Device Name:DERMATEC TRANSPARENT FILM DRESSING
ClassificationDressing, Wound, Drug
Applicant DERMATEC, INC. 549 HOWE AVE. Shelton,  CT  06484
ContactSteven M Tuchband
CorrespondentSteven M Tuchband
DERMATEC, INC. 549 HOWE AVE. Shelton,  CT  06484
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-08-28
Decision Date1986-12-31

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