Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K914277 |
Device Name |
WALLSTENT(R) TRANS BILIARY ENDO W/UNISTEP DELIV SY |
Applicant |
SCHNEIDER U.S. STENT DIV. |
5905 NATHAN LN. |
MINNEAPOLIS,
MN
55442
|
|
Applicant Contact |
RUSSELL W OLSON |
Correspondent |
SCHNEIDER U.S. STENT DIV. |
5905 NATHAN LN. |
MINNEAPOLIS,
MN
55442
|
|
Correspondent Contact |
RUSSELL W OLSON |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 09/24/1991 |
Decision Date | 11/29/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|