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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 K991533
Device Name MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICATION
Applicant
PERIPHERAL AVE
2330 CIRCADIAN WAY
SANTA ROSA,  CA  95403 -5415
Applicant Contact SUSAN WALTON
Correspondent
PERIPHERAL AVE
2330 CIRCADIAN WAY
SANTA ROSA,  CA  95403 -5415
Correspondent Contact SUSAN WALTON
Regulation Number876.5010
Classification Product Code
FGE  
Date Received05/03/1999
Decision Date 07/29/1999
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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