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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 K904411
Device Name INTRASITE GEL (LABELING REVISION)
Applicant
Smith & Nephew United, Inc.
11775 Starkley Rd.
P.O.Box 1970
Largo,  FL  34649
Applicant Contact JIM IRVINE
Correspondent
Smith & Nephew United, Inc.
11775 Starkley Rd.
P.O.Box 1970
Largo,  FL  34649
Correspondent Contact JIM IRVINE
Regulation Number880.5090
Classification Product Code
KMF  
Date Received09/26/1990
Decision Date 11/26/1990
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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