Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K885180 |
Device Name |
EXPANDABLE BILIARY STENT ENDOPROSTHESIS |
Applicant |
SCHNEIDER INTL., LTD. |
2905 NORTHWEST BLVD. |
MINNEAPOLIS,
MN
55441
|
|
Applicant Contact |
ALAN MARQUARDT |
Correspondent |
SCHNEIDER INTL., LTD. |
2905 NORTHWEST BLVD. |
MINNEAPOLIS,
MN
55441
|
|
Correspondent Contact |
ALAN MARQUARDT |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 12/14/1988 |
Decision Date | 02/16/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|