Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K093003 |
Device Name |
BONASTENT BILIARY |
Applicant |
ENDOCHOICE, INC. |
1914 J.N. PEASE PLACE |
CHARLOTTE,
NC
28262
|
|
Applicant Contact |
SHOSHANA FRIEDMAN |
Correspondent |
ENDOCHOICE, INC. |
1914 J.N. PEASE PLACE |
CHARLOTTE,
NC
28262
|
|
Correspondent Contact |
SHOSHANA FRIEDMAN |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 09/28/2009 |
Decision Date | 03/24/2010 |
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
|
|
|