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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K991933
Device Name DERMAPHYLYX FOAM ISLAND DRESSING
Applicant
DERMAPHYLYX, INC.
12106, WEST 75TH LN.
ARVADA,  CO  80005 -5306
Applicant Contact ANDREW M REED
Correspondent
DERMAPHYLYX, INC.
12106, WEST 75TH LN.
ARVADA,  CO  80005 -5306
Correspondent Contact ANDREW M REED
Regulation Number880.5090
Classification Product Code
KMF  
Date Received06/08/1999
Decision Date 07/30/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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