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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape And Bandage, Adhesive
510(k) Number K895353
Device Name OPSITE I.V. 3000
Applicant
Smith & Nephew United, Inc.
11775 Starkley Rd.
P.O.Box 1970
Largo,  FL  34649
Applicant Contact JIM IRVIN
Correspondent
Smith & Nephew United, Inc.
11775 Starkley Rd.
P.O.Box 1970
Largo,  FL  34649
Correspondent Contact JIM IRVIN
Regulation Number880.5240
Classification Product Code
KGX  
Date Received09/01/1989
Decision Date 09/28/1989
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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