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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K932664
Device Name ENCORE POWDER-FREE SURGICAL GLOVES ORTHOPAEDIA
Applicant
Smith & Nephew Perry
1875 Harsh Ave. SE
Massillon,  OH  44646
Applicant Contact WILLIAM E PATTON
Correspondent
Smith & Nephew Perry
1875 Harsh Ave. SE
Massillon,  OH  44646
Correspondent Contact WILLIAM E PATTON
Regulation Number878.4460
Classification Product Code
KGO  
Date Received06/02/1993
Decision Date 12/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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