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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 K972336
Device Name DERMAMEND HYDROGEL GAUZE DRESSING
Applicant
Dermarx Corp.
400 S. Colorado Blvd.,#420
Denver,  CO  80222
Applicant Contact MARYANNE CARROLL
Correspondent
Dermarx Corp.
400 S. Colorado Blvd.,#420
Denver,  CO  80222
Correspondent Contact MARYANNE CARROLL
Regulation Number880.5090
Classification Product Code
KMF  
Date Received06/23/1997
Decision Date 07/29/1997
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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