COMFEEL SEASORB DRESSING

Bandage, Liquid

COLOPLAST CORP.

The following data is part of a premarket notification filed by Coloplast Corp. with the FDA for Comfeel Seasorb Dressing.

Pre-market Notification Details

Device IDK983519
510k NumberK983519
Device Name:COMFEEL SEASORB DRESSING
ClassificationBandage, Liquid
Applicant COLOPLAST CORP. 1955 WEST OAK CIR. Marietta,  GA  30062 -2249
ContactM.sydney Lilly
CorrespondentM.sydney Lilly
COLOPLAST CORP. 1955 WEST OAK CIR. Marietta,  GA  30062 -2249
Product CodeKMF  
CFR Regulation Number880.5090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-10-08
Decision Date1998-12-30
Summary:summary

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