Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K050103 |
Device Name |
XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM |
Applicant |
ABBOTT LABORATORIES |
400 SAGINAW DR. |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
ANN E LEONARD |
Correspondent |
ABBOTT LABORATORIES |
400 SAGINAW DR. |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
ANN E LEONARD |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 01/18/2005 |
Decision Date | 02/16/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|