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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystoscope And Accessories, Flexible/Rigid
510(k) Number K223926
Device Name VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box
Applicant
Medimaging Integrated Solution, Inc (Miis)
3f., # 24-2, Industry E. Rd. Iv, Hsinchu Science Park
Hsinchu,  CN 30077
Applicant Contact Jung-Yi Yen
Correspondent
Medimaging Integrated Solution, Inc (Miis)
3f., # 24-2, Industry E. Rd. Iv, Hsinchu Science Park
Hsinchu,  CN 30077
Correspondent Contact Luu Hsu
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received12/30/2022
Decision Date 10/06/2023
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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