Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K982005 |
Device Name |
WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS |
Applicant |
BOSTON SCIENTIFIC SCIMED, INC. |
5905 NATHAN LN. |
MINNEAPOLIS,
MN
55442
|
|
Applicant Contact |
RONALD W BENNETT |
Correspondent |
BOSTON SCIENTIFIC SCIMED, INC. |
5905 NATHAN LN. |
MINNEAPOLIS,
MN
55442
|
|
Correspondent Contact |
RONALD W BENNETT |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 06/08/1998 |
Decision Date | 09/02/1998 |
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
|
|
|