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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 K861441
Device Name NEUTRALON SURGICAL GLOVES
Applicant
Surgikos, Inc.
P.O. Box 130
Arlington,  TX  76010
Applicant Contact CHRISTAL O FISHER
Correspondent
Surgikos, Inc.
P.O. Box 130
Arlington,  TX  76010
Correspondent Contact CHRISTAL O FISHER
Regulation Number878.4460
Classification Product Code
KGO  
Date Received04/17/1986
Decision Date 05/30/1986
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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