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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 K890459
Device Name JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVES
Applicant
James River Corp.
1915 Marathon Ave.
Neenah,  WI  54956
Applicant Contact RICHARD L DAVIS
Correspondent
James River Corp.
1915 Marathon Ave.
Neenah,  WI  54956
Correspondent Contact RICHARD L DAVIS
Regulation Number878.4460
Classification Product Code
KGO  
Date Received01/30/1989
Decision Date 04/20/1989
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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