Device Classification Name |
catheter, nephrostomy
|
510(k) Number |
K191498 |
Device Name |
Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc |
Applicant |
Cook Incorporated |
750 Daniels Way |
Bloomington,
IN
47404
|
|
Applicant Contact |
Carly Powell |
Correspondent |
Cook Incorporated |
750 Daniels Way |
Bloomington,
IN
47404
|
|
Correspondent Contact |
Carly Powell |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/05/2019 |
Decision Date | 01/29/2020 |
Decision |
Substantially Equivalent - Kit
(SESK) |
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|