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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 K943674
Device Name NEUTRALON LP BROWN LATEX SURGICAL GLOVES
Applicant
Maxxim Medical
2500 Arbrook Blvd.
P.O. Box 90130
Arlington,  TX  76004
Applicant Contact LINDA G HILL
Correspondent
Maxxim Medical
2500 Arbrook Blvd.
P.O. Box 90130
Arlington,  TX  76004
Correspondent Contact LINDA G HILL
Regulation Number878.4460
Classification Product Code
KGO  
Date Received07/26/1994
Decision Date 02/13/1995
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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