Device Classification Name |
Stent, Ureteral
|
510(k) Number |
K173734 |
Device Name |
RocaJJ Soft Stents |
Applicant |
Promepla SAM |
9 Avenue Albert II |
Monaco,
MC
98000
|
|
Applicant Contact |
Alexandre Bareille |
Correspondent |
Promepla SAM |
9 Avenue Albert II |
Monaco,
MC
98000
|
|
Correspondent Contact |
Alexandre Bareille |
Regulation Number | 876.4620
|
Classification Product Code |
|
Date Received | 12/06/2017 |
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
|
|
|