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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 K900587
Device Name SEMPERMED SURGEON'S GLOVES
Applicant
Semperit Industrial Products
103 Spring Valley Rd.
Montvale,  NJ  07645
Applicant Contact MANFRED F REICHEL
Correspondent
Semperit Industrial Products
103 Spring Valley Rd.
Montvale,  NJ  07645
Correspondent Contact MANFRED F REICHEL
Regulation Number878.4460
Classification Product Code
KGO  
Date Received02/07/1990
Decision Date 07/03/1990
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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