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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 K895764
Device Name MODIFIED LYOFOAM WOUND DRESSINGS
Applicant
ACME UNITED CORP.
425 POST RD.
FAIRFIELD,  CT  06430
Applicant Contact A. T HARRISON
Correspondent
ACME UNITED CORP.
425 POST RD.
FAIRFIELD,  CT  06430
Correspondent Contact A. T HARRISON
Regulation Number880.5090
Classification Product Code
KMF  
Date Received09/26/1989
Decision Date 09/10/1990
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
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