Device Classification Name |
dilator, catheter, ureteral
|
510(k) Number |
K132181 |
Device Name |
GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER |
Applicant |
OLYMPUS SURGICAL TECHNOLOGIES AMERICA |
136 TURNPIKE ROAD |
SOUTHBOROUGH,
MA
01772
|
|
Applicant Contact |
NEIL KELLY |
Correspondent |
OLYMPUS SURGICAL TECHNOLOGIES AMERICA |
136 TURNPIKE ROAD |
SOUTHBOROUGH,
MA
01772
|
|
Correspondent Contact |
NEIL KELLY |
Regulation Number | 876.5470
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/15/2013 |
Decision Date | 10/21/2013 |
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
|
|
|