Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K081184 |
Device Name |
GORE VIABIL BILILARY ENDOPROSTHESIS |
Applicant |
W.L. GORE & ASSOCIATES INC, MEDICAL PRODUCTS DIV. |
3250 WEST KILTIE LN. |
FLAGSTAFF,
AZ
86002 -0500
|
|
Applicant Contact |
Michael Ivey |
Correspondent |
W.L. GORE & ASSOCIATES INC, MEDICAL PRODUCTS DIV. |
3250 WEST KILTIE LN. |
FLAGSTAFF,
AZ
86002 -0500
|
|
Correspondent Contact |
Michael Ivey |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 04/25/2008 |
Decision Date | 07/22/2008 |
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
|
|
|