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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 K884425
Device Name GLOVE, SURGICAL
Applicant
Med-Pak Corp.
3497 Ashby
Ville St.-Laurent, Quebec
Canada H4r 2k3,  CA
Applicant Contact PIERRE LEBLANC
Correspondent
Med-Pak Corp.
3497 Ashby
Ville St.-Laurent, Quebec
Canada H4r 2k3,  CA
Correspondent Contact PIERRE LEBLANC
Regulation Number878.4460
Classification Product Code
KGO  
Date Received10/20/1988
Decision Date 02/06/1989
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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