COMFEEL BARRIER CREAM

Collector, Ostomy

COLOPLAST A/S

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

Pre-market Notification Details

Device IDK833569
510k NumberK833569
Device Name:COMFEEL BARRIER CREAM
ClassificationCollector, Ostomy
Applicant COLOPLAST A/S 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEXB  
CFR Regulation Number876.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-10-12
Decision Date1983-12-27

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