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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sheet, Burn
510(k) Number K871740
Device Name LYOSHEET SURGICAL SHEET FOR BURNS
Applicant
Acme United Corp.
425 Post Rd.
Fairfield,  CT  06430
Applicant Contact SUSAN L CAREY
Correspondent
Acme United Corp.
425 Post Rd.
Fairfield,  CT  06430
Correspondent Contact SUSAN L CAREY
Regulation Number880.5180
Classification Product Code
FPY  
Date Received05/05/1987
Decision Date 06/09/1987
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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