MODIFICATION TO WOUN'DRES

Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

COLOPLAST CORP.

The following data is part of a premarket notification filed by Coloplast Corp. with the FDA for Modification To Woun'dres.

Pre-market Notification Details

Device IDK991202
510k NumberK991202
Device Name:MODIFICATION TO WOUN'DRES
ClassificationDressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Applicant COLOPLAST CORP. 1940 COMMERCE DR. P.O. BOX 8300 North Mankato,  MN  56003 -8300
ContactHarvey M Arbit
CorrespondentHarvey M Arbit
COLOPLAST CORP. 1940 COMMERCE DR. P.O. BOX 8300 North Mankato,  MN  56003 -8300
Product CodeMGQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-22
Decision Date1999-06-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00311701161564 K991202 000
00311701161526 K991202 000

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