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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, ureteral, gastro-urology
510(k) Number K192183
Device Name RocaTub Ureteral Catheter
Promepal Sam
9 Avenue Albert II
Monaco,  MC 98000
Applicant Contact Mohamed Rekik
Promepal Sam
9 Avenue Albert II
Monaco,  MC 98000
Correspondent Contact Mohamed Rekik
Regulation Number876.5130
Classification Product Code
Date Received08/12/2019
Decision Date 04/23/2020
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