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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 K983008
Device Name PERIPHERAL AVE STENT SYSTEM
Applicant
PERIPHERAL AVE
2330A CIRCADIAN WAY
SANTA ROSA,  CA  95404
Applicant Contact PAUL MEYER
Correspondent
PERIPHERAL AVE
2330A CIRCADIAN WAY
SANTA ROSA,  CA  95404
Correspondent Contact PAUL MEYER
Regulation Number876.5010
Classification Product Code
FGE  
Date Received08/28/1998
Decision Date 11/25/1998
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
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