COMFEEL CONTOUR DRESSING

Bandage, Liquid

COLOPLAST A/S

The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Comfeel Contour Dressing.

Pre-market Notification Details

Device IDK920925
510k NumberK920925
Device Name:COMFEEL CONTOUR DRESSING
ClassificationBandage, Liquid
Applicant COLOPLAST A/S C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth,  TX  76162
ContactRichard A Hamer
CorrespondentRichard A Hamer
COLOPLAST A/S C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth,  TX  76162
Product CodeKMF  
CFR Regulation Number880.5090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-02-28
Decision Date1992-05-28

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