Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K103478 |
Device Name |
SINGLE USE BILIARY DRAINAGE STENT V |
Applicant |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
3500 CORPORATE PARKWAY |
PO BOX 610 |
CENTER VALLEY,
PA
18034 -0610
|
|
Applicant Contact |
STACY ABBATIELLO KLUESNER |
Correspondent |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
3500 CORPORATE PARKWAY |
PO BOX 610 |
CENTER VALLEY,
PA
18034 -0610
|
|
Correspondent Contact |
STACY ABBATIELLO KLUESNER |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 11/26/2010 |
Decision Date | 02/24/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|