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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 K880299
Device Name REPLICARE
Applicant
United Medical
11775 Starkey Rd.
P.O. Box 1970
Largo,  FL  34649
Applicant Contact JIM IRVIN
Correspondent
United Medical
11775 Starkey Rd.
P.O. Box 1970
Largo,  FL  34649
Correspondent Contact JIM IRVIN
Classification Product Code
FRO  
Date Received01/25/1988
Decision Date 02/26/1988
Decision Substantially Equivalent (SESE)
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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