Device Classification Name |
stent, ureteral
|
510(k) Number |
K170010 |
Device Name |
Salle Intraoperative Pyeloplasty Stent Set |
Applicant |
COOK INCORPORATED |
750 DANIELS WAY |
BLOOMINGTON,
IN
47404
|
|
Applicant Contact |
MINJIN CHOI |
Correspondent |
COOK INCORPORATED |
750 DANIELS WAY |
BLOOMINGTON,
IN
47404
|
|
Correspondent Contact |
MINJIN CHOI |
Regulation Number | 876.4620
|
Classification Product Code |
|
Date Received | 01/03/2017 |
Decision Date | 08/28/2017 |
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
|
|
|