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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K063835
Device Name ALLEVYN AG DRESSING
Applicant
Smith & Nephew, Inc.
11775 Starkey Rd.
Largo,  FL  33773
Applicant Contact TERRY MCMAHON
Correspondent
Smith & Nephew, Inc.
11775 Starkey Rd.
Largo,  FL  33773
Correspondent Contact TERRY MCMAHON
Classification Product Code
FRO  
Date Received12/26/2006
Decision Date 08/03/2007
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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