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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Beads, Hydrophilic, For Wound Exudate Absorption
510(k) Number K904412
Device Name ALLEVYN DRESSING CLAIMS CHANGE
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 Number878.4018
Classification Product Code
KOZ  
Date Received09/26/1990
Decision Date 10/23/1990
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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