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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 K953641
Device Name MAXXUS ORTHOPAEDIC SURGICAL GLOVES
Applicant
JOHNSON & JOHNSON MEDICAL, INC.
2500 ARBROOK BLVD.
P.O. BOX 90130
ARLINGTON,  TX  76004 -0130
Applicant Contact MARGARET L MARSH
Correspondent
JOHNSON & JOHNSON MEDICAL, INC.
2500 ARBROOK BLVD.
P.O. BOX 90130
ARLINGTON,  TX  76004 -0130
Correspondent Contact MARGARET L MARSH
Regulation Number878.4460
Classification Product Code
KGO  
Date Received08/04/1995
Decision Date 09/15/1995
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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