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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 K223040
Device Name Endo SmartCap
Applicant
Medivators Inc
14605 28th Ave North
Minneapolis,  MN  55447
Applicant Contact Disha Kabrawala
Correspondent
Medivators Inc
14605 28th Ave North
Minneapolis,  MN  55447
Correspondent Contact Disha Kabrawala
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received09/29/2022
Decision Date 03/01/2023
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
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