Device Classification Name |
catheter, hemodialysis, non-implanted
|
510(k) Number |
K122091 |
Device Name |
COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY |
Applicant |
COOK, INC. |
750 DANIELS WAY |
Blmgtn,
IN
47404
|
|
Applicant Contact |
SEAN SPENCE |
Correspondent |
COOK, INC. |
750 DANIELS WAY |
Blmgtn,
IN
47404
|
|
Correspondent Contact |
SEAN SPENCE |
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 07/16/2012 |
Decision Date | 07/29/2013 |
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
|
|
|