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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 K193600
Device Name EndoGI Biliary Stent System
Applicant
Endogi Medical, Ltd.
13wadi El Hadj
Nazareth,  IL
Applicant Contact Omri Naveh
Correspondent
ProMedoss, Inc.
3521 Hatwynn Rd.
Charlott,  NC  28269
Correspondent Contact Bosmat Friedman
Regulation Number876.5010
Classification Product Code
FGE  
Date Received12/23/2019
Decision Date 06/26/2020
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 No
Predetermined Change
Control Plan Authorized		 No
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