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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 K896165
Device Name STERILE HYPOALLERGENIC SURGEONS' GLOVES
Applicant
ISRATECH MARKETING CORP.
200 MADISON AVE.
NEW YORK,  NY  10016
Applicant Contact EFRAIM MARGOLIN
Correspondent
ISRATECH MARKETING CORP.
200 MADISON AVE.
NEW YORK,  NY  10016
Correspondent Contact EFRAIM MARGOLIN
Regulation Number878.4460
Classification Product Code
KGO  
Date Received10/25/1989
Decision Date 11/22/1989
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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