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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K864084
Device Name LYOFOAM C ODOR-ABSORBING DRESSING
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
Classification Product Code
FRO  
Date Received10/20/1986
Decision Date 11/21/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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