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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 K081996
Device Name FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM
Applicant
Flexible Stenting Solutions, Inc.
23 Christopher Way
Eatontown,  NJ  07724
Applicant Contact JOSEPH C GRIFFIN
Correspondent
Flexible Stenting Solutions, Inc.
23 Christopher Way
Eatontown,  NJ  07724
Correspondent Contact JOSEPH C GRIFFIN
Regulation Number876.5010
Classification Product Code
FGE  
Date Received07/14/2008
Decision Date 09/15/2009
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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