Device Classification Name |
Dilator, Catheter, Ureteral
|
510(k) Number |
K040127 |
Device Name |
COOK URETERAL BALLOON DILATION CATHETER SET |
Applicant |
COOK UROLOGICAL, INC. |
1100 WEST MORGAN ST. |
SPENCER,
IN
47460
|
|
Applicant Contact |
DEBBIE SCHMITT |
Correspondent |
COOK UROLOGICAL, INC. |
1100 WEST MORGAN ST. |
SPENCER,
IN
47460
|
|
Correspondent Contact |
DEBBIE SCHMITT |
Regulation Number | 876.5470
|
Classification Product Code |
|
Date Received | 01/21/2004 |
Decision Date | 04/06/2004 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|