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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stent, ureteral
510(k) Number K212868
Device Name JFil Ureteral Stents, JFil Ureteral Stents ECO KIT
Rocamed SAM
9 Avenue Albert II
Monaco,  MC 98000
Applicant Contact Tahiana Rasolofoniaina
Rocamed SAM
9 Avenue Albert II
Monaco,  MC 98000
Correspondent Contact Tahiana Rasolofoniaina
Regulation Number876.4620
Classification Product Code
Date Received09/09/2021
Decision Date 01/26/2022
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