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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 K000744
Device Name MEDTRONIC AVE BRIDGE X3 STENT
Applicant
MEDTRONIC AVE, INC.
2170 NORTHPOINT PKWY.
SANTA ROSA,  CA  95407
Applicant Contact SUSAN WALTON
Correspondent
MEDTRONIC AVE, INC.
2170 NORTHPOINT PKWY.
SANTA ROSA,  CA  95407
Correspondent Contact SUSAN WALTON
Regulation Number876.5010
Classification Product Code
FGE  
Date Received03/07/2000
Decision Date 06/05/2000
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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