Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K143303 |
Device Name |
Single Use Biliary Balloon Dilator |
Applicant |
OLYMPUS MEDICAL SYSTEMS CORP. |
2951 ISHIKAWA-CHO |
HACHIOJI,
JP
192-8507
|
|
Applicant Contact |
Sheri Musgnung |
Correspondent |
OLYMPUS CORPORATION OF THE AMERICAS |
3500 CORPORATE PARKWAY |
PO BOX 610 |
CENTER VALLEY,
PA
18034 -0610
|
|
Correspondent Contact |
Sheri L Musgnung |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 11/18/2014 |
Decision Date | 02/27/2015 |
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
|
|
|