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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Drainage, Suprapubic
510(k) Number K944290
Device Name CATHETERS, BILIARY CATHETERS, UROLOGICAL
Applicant
Boston Scientific Corp
780 Brookside Dr.
Spencer,  IN  47460
Applicant Contact LORRAIN M HANLEY
Correspondent
Boston Scientific Corp
780 Brookside Dr.
Spencer,  IN  47460
Correspondent Contact LORRAIN M HANLEY
Regulation Number876.5090
Classification Product Code
FFA  
Subsequent Product Codes
FAD   FGE   LJE  
Date Received09/02/1994
Decision Date 12/08/1994
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
Recalls CDRH Recalls
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