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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 K961452
Device Name LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING
Applicant
ACME UNITED CORP.
75 KINGS HWY. CUT-OFF
FAIRFIELD,  CT  06430
Applicant Contact THOMAS E FLYNN
Correspondent
ACME UNITED CORP.
75 KINGS HWY. CUT-OFF
FAIRFIELD,  CT  06430
Correspondent Contact THOMAS E FLYNN
Regulation Number880.5090
Classification Product Code
KMF  
Date Received04/16/1996
Decision Date 05/31/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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