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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dislodger, Stone, Flexible
510(k) Number K893522
Device Name SURGEON'S GLOVES
Applicant
Thai Fuji Latex Co., Ltd.
650 California St.
Suite 2550
San Francisco,  CA  94108
Applicant Contact ROGER J FLEISCHMANN
Correspondent
Thai Fuji Latex Co., Ltd.
650 California St.
Suite 2550
San Francisco,  CA  94108
Correspondent Contact ROGER J FLEISCHMANN
Regulation Number876.4680
Classification Product Code
FGO  
Date Received05/08/1989
Decision Date 01/22/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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