Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K003793 |
Device Name |
BARD LUMINEXX BILIARY STENT |
Applicant |
C.R. BARD, INC. |
13183 HARLAND DRIVE |
COVINGTON,
GA
30014 -6421
|
|
Applicant Contact |
CAROL VIERLING |
Correspondent |
C.R. BARD, INC. |
13183 HARLAND DRIVE |
COVINGTON,
GA
30014 -6421
|
|
Correspondent Contact |
CAROL VIERLING |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 12/08/2000 |
Decision Date | 01/05/2001 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|