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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic access overtube, gastroenterology-urology
510(k) Number K171208
Device Name Trans-anal Introducer
Applicant
Visionsense Ltd.
20 Hamagshimim St.
Petach Tikva, Hamerkaz,  IL 49348
Applicant Contact Alex Chanin
Correspondent
Visionsense Ltd.
68 Southwoods Terrace
Southbury,  CT  06488
Correspondent Contact Raymond Kelly
Regulation Number876.1500
Classification Product Code
FED  
Subsequent Product Code
FAM  
Date Received04/25/2017
Decision Date 02/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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