DERMAPHYLYX FOAM ISLAND DRESSING

Bandage, Liquid

DERMAPHYLYX, INC.

The following data is part of a premarket notification filed by Dermaphylyx, Inc. with the FDA for Dermaphylyx Foam Island Dressing.

Pre-market Notification Details

Device IDK991933
510k NumberK991933
Device Name:DERMAPHYLYX FOAM ISLAND DRESSING
ClassificationBandage, Liquid
Applicant DERMAPHYLYX, INC. 12106, WEST 75TH LN. Arvada,  CO  80005 -5306
ContactAndrew M Reed
CorrespondentAndrew M Reed
DERMAPHYLYX, INC. 12106, WEST 75TH LN. Arvada,  CO  80005 -5306
Product CodeKMF  
CFR Regulation Number880.5090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-06-08
Decision Date1999-07-30

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