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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gastroscope and accessories, flexible/rigid
510(k) Number K180911
Device Name Visura Technologies TEECAD System
Applicant
Visura Technologies, LLC
9337 Harding Avenue
Evanston,  IL  60203
Applicant Contact Eric Sandberg
Correspondent
Valleygrey Enterprise
396 N. Whisman Rd.
Mountain View,  CA  94043
Correspondent Contact Gina Correa
Regulation Number876.1500
Classification Product Code
FDS  
Subsequent Product Code
ITX  
Date Received04/06/2018
Decision Date 06/20/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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