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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 K992318
Device Name MEDTRONIC AVE BRIDGE STENT
Applicant
MEDTRONIC AVE, INC.
2330A CIRCADIAN WAY
SANTA ROSA,  CA  95407 -5415
Applicant Contact SUSAN WALTON
Correspondent
MEDTRONIC AVE, INC.
2330A CIRCADIAN WAY
SANTA ROSA,  CA  95407 -5415
Correspondent Contact SUSAN WALTON
Regulation Number876.5010
Classification Product Code
FGE  
Date Received07/12/1999
Decision Date 08/02/1999
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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