Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K021994 |
Device Name |
BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM |
Applicant |
C.R. BARD, INC. |
1625 WEST 3RD ST. |
TEMPE,
AZ
85281 -2438
|
|
Applicant Contact |
AYMEE BERRY |
Correspondent |
C.R. BARD, INC. |
1625 WEST 3RD ST. |
TEMPE,
AZ
85281 -2438
|
|
Correspondent Contact |
AYMEE BERRY |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 06/18/2002 |
Decision Date | 01/02/2003 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|