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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 K882595
Device Name MEDICAL GLOVES STERILE LATEX SURGEONS DIGIFORM
Applicant
Marathon Management Co.
67a Steelcase Rd. W., L3r
2m4
Markham, Ontario,  CA
Applicant Contact LEON WEIN
Correspondent
Marathon Management Co.
67a Steelcase Rd. W., L3r
2m4
Markham, Ontario,  CA
Correspondent Contact LEON WEIN
Regulation Number878.4460
Classification Product Code
KGO  
Date Received06/24/1988
Decision Date 10/04/1988
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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