Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K072720 |
Device Name |
ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM |
Applicant |
ALVEOLUS, INC. |
9013 PERIMETER WOODS DRIVE |
SUITE A |
CHARLOTTE,
NC
28216
|
|
Applicant Contact |
TONY D ALEXANDER |
Correspondent |
ALVEOLUS, INC. |
9013 PERIMETER WOODS DRIVE |
SUITE A |
CHARLOTTE,
NC
28216
|
|
Correspondent Contact |
TONY D ALEXANDER |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 09/25/2007 |
Decision Date | 04/11/2008 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|