BIATAIN FOAM DRESSING

Dressing, Wound And Burn, Occlusive

COLOPLAST CORP.

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

Pre-market Notification Details

Device IDK983163
510k NumberK983163
Device Name:BIATAIN FOAM DRESSING
ClassificationDressing, Wound And Burn, Occlusive
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 CodeMGP  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-10
Decision Date1998-12-16
Summary:summary

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