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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 K984064
Device Name OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE
Applicant
Omni Intl., Inc.
4916 Spruce Hill Dr. NW
Canton,  OH  44718
Applicant Contact WILLIAM E PATTON
Correspondent
Omni Intl., Inc.
4916 Spruce Hill Dr. NW
Canton,  OH  44718
Correspondent Contact WILLIAM E PATTON
Regulation Number878.4460
Classification Product Code
KGO  
Date Received11/16/1998
Decision Date 01/08/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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