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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal
510(k) Number K891460
Device Name NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USE
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
Classification Product Code
EFQ  
Date Received03/15/1989
Decision Date 04/17/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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