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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 K234033
Device Name ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)
Applicant
Boehringer Laboratories LLC
300 Thoms Dr
Phoenixville,  PA  19460
Applicant Contact Ondrej Nikel
Correspondent
Boehringer Laboratories LLC
300 Thoms Dr
Phoenixville,  PA  19460
Correspondent Contact Ondrej Nikel
Regulation Number876.5980
Classification Product Code
KNT  
Date Received12/20/2023
Decision Date 05/06/2024
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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