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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implanted Tibial Electrical Urinary Continence Device
510(k) Number K240037
Device Name Revi™ System
Applicant
Bluewind Medical , Ltd.
6 Maskit St.
Herzliya,  IL 4614002
Applicant Contact Jason Woehrle
Correspondent
Bluewind Medical , Ltd.
6 Maskit St.
Herzliya,  IL 4614002
Correspondent Contact Jason Woehrle
Classification Product Code
QXM  
Date Received01/05/2024
Decision Date 05/02/2024
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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