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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 K072708
Device Name ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM
Applicant
ABBOTT VASCULAR-VASCULAR SOLUTIONS
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054
Applicant Contact MICHELLE GROSSMAN
Correspondent
ABBOTT VASCULAR-VASCULAR SOLUTIONS
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054
Correspondent Contact MICHELLE GROSSMAN
Regulation Number876.5010
Classification Product Code
FGE  
Date Received09/25/2007
Decision Date 08/18/2008
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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