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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 K954919
Device Name MEROCEL SOFT WOUND DRESSING
Applicant
Merocel Corp.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216
Applicant Contact DAVID TIMLIN
Correspondent
Merocel Corp.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216
Correspondent Contact DAVID TIMLIN
Regulation Number880.5090
Classification Product Code
KMF  
Date Received10/26/1995
Decision Date 11/14/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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