Device Classification Name |
Cannula, Manipulator/Injector, Uterine
|
510(k) Number |
K150519 |
Device Name |
ManipulatOR PRO, ManipulatOR |
Applicant |
GYNETECH PTY. LTD. |
122-124 Balmain Street |
Richmond,
AU
3121
|
|
Applicant Contact |
Brett Telford |
Correspondent |
QUINTILES CONSULTING |
1801 ROCKVILLE PIKE, SUITE 300 |
ROCKVILLE,
MD
20852
|
|
Correspondent Contact |
Christopher M Sloan |
Regulation Number | 884.4530 |
Classification Product Code |
|
Date Received | 03/02/2015 |
Decision Date | 08/19/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|