Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K844384 |
Device Name |
BILIARY STENT PROSTHESIS |
Applicant |
MENTOR CORP. |
600 PINE AVE. |
GOLETA,
CA
93117
|
|
Applicant Contact |
CHRISTINE EMANUEL |
Correspondent |
MENTOR CORP. |
600 PINE AVE. |
GOLETA,
CA
93117
|
|
Correspondent Contact |
CHRISTINE EMANUEL |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 11/13/1984 |
Decision Date | 02/14/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|