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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 K881374
Device Name SURGEONS GLOVES
Applicant
INTERPRO INTL., INC.
2 VIEWPOINT TERRACE
LEBANON,  NJ  08833
Applicant Contact KENNETH W SIMMS
Correspondent
INTERPRO INTL., INC.
2 VIEWPOINT TERRACE
LEBANON,  NJ  08833
Correspondent Contact KENNETH W SIMMS
Regulation Number878.4460
Classification Product Code
KGO  
Date Received04/01/1988
Decision Date 08/05/1988
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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