Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K032360 |
Device Name |
MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM AND EXPRESS BILIARY LD UNMOUNTED STENT |
Applicant |
BOSTON SCIENTIFIC CORP. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Applicant Contact |
TODD KORNMANN |
Correspondent |
BOSTON SCIENTIFIC CORP. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Correspondent Contact |
TODD KORNMANN |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 07/31/2003 |
Decision Date | 08/27/2003 |
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
|