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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K234145
Device Name ViSiGi 3D Gastric Sizing Tube
Applicant
Boehringer Laboratories
300 Thoms Dr.
Phoenixville,  PA  19460
Applicant Contact Nathan Simasek
Correspondent
Boehringer Laboratories
300 Thoms Dr.
Phoenixville,  PA  19460
Correspondent Contact Nathan Simasek
Regulation Number876.5980
Classification Product Code
KNT  
Date Received12/29/2023
Decision Date 01/26/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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