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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ureteroscope and accessories, flexible/rigid
510(k) Number K181977
Device Name WiScope Digital Endoscope System
Applicant
OTU Medical Inc.
2231A Fortune Drive
San Jose,  CA  95131
Applicant Contact Doris Dong
Correspondent
THIRD PARTY REVIEW GROUP, LLC
25 Independence Blvd
Warren,  NJ  07059
Correspondent Contact David Yungvirt
Regulation Number876.1500
Classification Product Code
FGB  
Date Received07/24/2018
Decision Date 08/14/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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