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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 K903513
Device Name SANOFLEX-STERILE LATEX SURGICAL GLOVES
Applicant
Lowenkamp Intl., Inc.
P.O. Box 878
Hazlehurst,  MS  39083
Applicant Contact WILLIAM C LOWENKAMP
Correspondent
Lowenkamp Intl., Inc.
P.O. Box 878
Hazlehurst,  MS  39083
Correspondent Contact WILLIAM C LOWENKAMP
Regulation Number878.4460
Classification Product Code
KGO  
Date Received08/03/1990
Decision Date 09/14/1990
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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