Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K955728 |
Device Name |
CORDIS BILIARY STENT |
Applicant |
CORDIS CORP. |
14201 N.W. 60TH AVE. |
MIAMI LAKES,
FL
33014
|
|
Applicant Contact |
MARLENE W VALENTI |
Correspondent |
CORDIS CORP. |
14201 N.W. 60TH AVE. |
MIAMI LAKES,
FL
33014
|
|
Correspondent Contact |
MARLENE W VALENTI |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 12/18/1995 |
Decision Date | 05/08/1996 |
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
|
|
|