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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 K121125
Device Name FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
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 Received04/13/2012
Decision Date 07/06/2012
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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