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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 K893900
Device Name PRIMAPORE I.V.
Applicant
SMITH & NEPHEW UNITED, INC.
11775 STARKLEY RD.
P.O.BOX 1970
LARGO,  FL  34649 -1970
Applicant Contact KAREN L GERLACH
Correspondent
SMITH & NEPHEW UNITED, INC.
11775 STARKLEY RD.
P.O.BOX 1970
LARGO,  FL  34649 -1970
Correspondent Contact KAREN L GERLACH
Regulation Number880.5240
Classification Product Code
KGX  
Date Received06/16/1989
Decision Date 08/03/1989
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
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