Device Classification Name |
dilator, catheter, ureteral
|
510(k) Number |
K180028 |
Device Name |
Cook 810 Set, Desilets-Hoffman Introducer Set |
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 |
Regulation Number | 876.5470
|
Classification Product Code |
|
Date Received | 01/03/2018 |
Decision Date | 05/02/2018 |
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
|
|
|