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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 K940572
Device Name MEROCEL(R) WOUND DRESSING (WITH HEMOSTATIC CLAIM)
Applicant
Merocel Corp.
950 Flanders Rd.
Mystic,  CT  06355
Applicant Contact JOHN GAGLIARDI
Correspondent
Merocel Corp.
950 Flanders Rd.
Mystic,  CT  06355
Correspondent Contact JOHN GAGLIARDI
Regulation Number880.5090
Classification Product Code
KMF  
Date Received02/08/1994
Decision Date 06/07/1994
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
Predetermined Change
Control Plan Authorized		 No
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