Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K041962 |
Device Name |
XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587, 20588, 20589, 20603, 20604, 20605 |
Applicant |
ABBOTT LABORATORIES |
400 SAGINAW DR. |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
JOANNA KUSKOWSKI |
Correspondent |
ABBOTT LABORATORIES |
400 SAGINAW DR. |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
JOANNA KUSKOWSKI |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 07/21/2004 |
Decision Date | 10/01/2004 |
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
|
|
|