Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K072708 |
Device Name |
ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM |
Applicant |
ABBOTT VASCULAR-VASCULAR SOLUTIONS |
3200 LAKESIDE DR. |
SANTA CLARA,
CA
95054
|
|
Applicant Contact |
MICHELLE GROSSMAN |
Correspondent |
ABBOTT VASCULAR-VASCULAR SOLUTIONS |
3200 LAKESIDE DR. |
SANTA CLARA,
CA
95054
|
|
Correspondent Contact |
MICHELLE GROSSMAN |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 09/25/2007 |
Decision Date | 08/18/2008 |
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
|
|
|