Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K051124 |
Device Name |
ZILVER 635 BILIARY STENT |
Applicant |
COOK, INC. |
750 DANIELS WAY |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402
|
|
Applicant Contact |
STEPHANIE ROBERTS |
Correspondent |
COOK, INC. |
750 DANIELS WAY |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402
|
|
Correspondent Contact |
STEPHANIE ROBERTS |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 05/03/2005 |
Decision Date | 07/12/2005 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|