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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 -0334
Applicant Contact JOHN GAGLIARDI
Correspondent
MEROCEL CORP.
950 FLANDERS RD.
MYSTIC,  CT  06355 -0334
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
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