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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, Occlusive
510(k) Number K883849
Device Name REPLICARE (ADDITIONAL CLAIMS)
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
Regulation Number878.4020
Classification Product Code
NAD  
Date Received09/12/1988
Decision Date 02/08/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
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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