DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING

Bandage, Liquid

DERMAPHYLYX, INC.

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

Pre-market Notification Details

Device IDK991920
510k NumberK991920
Device Name:DERMAPHYLYX HYDROPHILIC FOAM WOUND 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 Received1999-06-07
Decision Date1999-08-12
Summary:summary

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