Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K143609 |
Device Name |
Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter |
Applicant |
OLYMPUS SURGICAL TECHNOLOGIES AMERICA |
136 TURNPIKE ROAD |
SOUTHBOROUGH,
MA
01772 -2104
|
|
Applicant Contact |
MARY ANNE PATELLA |
Correspondent |
OLYMPUS SURGICAL TECHNOLOGIES AMERICA |
136 TURNPIKE ROAD |
SOUTHBOROUGH,
MA
01772 -2104
|
|
Correspondent Contact |
MARY ANNE PATELLA |
Regulation Number | 876.5010
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/19/2014 |
Decision Date | 03/27/2015 |
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
|