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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 K173734
Device Name RocaJJ Soft Stents
Applicant
Promepla Sam
9 Ave. Albert Ii
Monaco,  MC 98000
Applicant Contact Alexandre Bareille
Correspondent
Promepla Sam
9 Ave. Albert Ii
Monaco,  MC 98000
Correspondent Contact Alexandre Bareille
Regulation Number876.4620
Classification Product Code
FAD  
Date Received12/06/2017
Decision Date 03/12/2018
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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