COMFEEL TRANSPARENT DRESSING

Tape And Bandage, Adhesive

COLOPLAST A/S

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

Pre-market Notification Details

Device IDK894916
510k NumberK894916
Device Name:COMFEEL TRANSPARENT DRESSING
ClassificationTape And Bandage, Adhesive
Applicant COLOPLAST A/S C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth,  TX  76162
ContactRichard Hamer
CorrespondentRichard Hamer
COLOPLAST A/S C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth,  TX  76162
Product CodeKGX  
CFR Regulation Number880.5240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-08-02
Decision Date1989-09-26

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