FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM

Stents, Drains And Dilators For The Biliary Ducts

FLEXIBLE STENTING SOLUTIONS, INC.

The following data is part of a premarket notification filed by Flexible Stenting Solutions, Inc. with the FDA for Flexstent Biliary Self-expanding Stent System.

Pre-market Notification Details

Device IDK121125
510k NumberK121125
Device Name:FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant FLEXIBLE STENTING SOLUTIONS, INC. 23 Christopher Way, Suite 103 Eatontown,  NJ  07724
ContactJoseph C Griffin Iii
CorrespondentJoseph C Griffin Iii
FLEXIBLE STENTING SOLUTIONS, INC. 23 Christopher Way, Suite 103 Eatontown,  NJ  07724
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSe - With Limitations (SESU)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-13
Decision Date2012-07-06

NIH GUDID Devices

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