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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 K864521
Device Name ANGEL LATEX SURGICAL GLOVES
Applicant
Kim Intl. Trading Co.
U.S. Hwy. 190 And Colfax St.
P.O. Box 29
Cameron,  TX  76520
Applicant Contact KIM, M.D.
Correspondent
Kim Intl. Trading Co.
U.S. Hwy. 190 And Colfax St.
P.O. Box 29
Cameron,  TX  76520
Correspondent Contact KIM, M.D.
Regulation Number878.4460
Classification Product Code
KGO  
Date Received11/17/1986
Decision Date 12/18/1986
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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