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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stents, drains and dilators for the biliary ducts
510(k) Number K011817
Device Name BRIDGE FX
Applicant
MEDTRONIC AVE, INC.
2170 NORTHPOINT PKWY.
SANTA ROSA,  CA  95407
Applicant Contact JOHN RIOLO
Correspondent
MEDTRONIC AVE, INC.
2170 NORTHPOINT PKWY.
SANTA ROSA,  CA  95407
Correspondent Contact JOHN RIOLO
Regulation Number876.5010
Classification Product Code
FGE  
Date Received06/11/2001
Decision Date 08/22/2001
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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