Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K030107 |
Device Name |
100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM |
Applicant |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PLACE |
NATICK,
MA
01760 -1537
|
|
Applicant Contact |
JENNIFER JOHNSON |
Correspondent |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PLACE |
NATICK,
MA
01760 -1537
|
|
Correspondent Contact |
JENNIFER JOHNSON |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 01/13/2003 |
Decision Date | 03/21/2003 |
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
|
Recalls |
CDRH Recalls
|
|
|