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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 K102519
Device Name FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX
Applicant
FLEXIBLE STENTING SOLUTIONS, INC.
23 CHRISTOPHER WAY
SUITE 103
EATONTOWN,  NJ  07724
Applicant Contact JOSEPH C GRIFFIN, III
Correspondent
FLEXIBLE STENTING SOLUTIONS, INC.
23 CHRISTOPHER WAY
SUITE 103
EATONTOWN,  NJ  07724
Correspondent Contact JOSEPH C GRIFFIN, III
Regulation Number876.5010
Classification Product Code
FGE  
Date Received09/02/2010
Decision Date 11/22/2010
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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