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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K964563
Device Name OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE
Applicant
Omni Sales Corp.
4916 Spruce Hill Dr., NW
Suite 300
Canton,  OH  44718
Applicant Contact WILLIAM E PATTON
Correspondent
Omni Sales Corp.
4916 Spruce Hill Dr., NW
Suite 300
Canton,  OH  44718
Correspondent Contact WILLIAM E PATTON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/14/1996
Decision Date 12/30/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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