Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K033537 |
Device Name |
SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005 |
Applicant |
ABBOTT LABORATORIES |
400 Saginaw Drive |
Redwood City,
CA
94063
|
|
Applicant Contact |
JOANNA KUSKOWSKI |
Correspondent |
ABBOTT LABORATORIES |
400 Saginaw Drive |
Redwood City,
CA
94063
|
|
Correspondent Contact |
JOANNA KUSKOWSKI |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 11/10/2003 |
Decision Date | 12/10/2003 |
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
|
|
|