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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 K181669
Device Name ConvertX Biliary Stent System
Applicant
Brightwater Medical
816 W. Bennett Ct.
Dunlap,  IL  61525
Applicant Contact Bob Smouse
Correspondent
Brightwater Medical
42580 Rio Nedo Rd.
Temecula,  CA  92590
Correspondent Contact Bob Smouse
Regulation Number876.5010
Classification Product Code
FGE  
Date Received06/25/2018
Decision Date 03/14/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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