The following data is part of a premarket notification filed by Gynetech Pty. Ltd. with the FDA for Manipulator Pro, Manipulator.
| Device ID | K150519 |
| 510k Number | K150519 |
| Device Name: | ManipulatOR PRO, ManipulatOR |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | GYNETECH PTY. LTD. 122-124 Balmain Street Richmond, AU 3121 |
| Contact | Brett Telford |
| Correspondent | Christopher M Sloan QUINTILES CONSULTING 1801 ROCKVILLE PIKE, SUITE 300 Rockville, MD 20852 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-02 |
| Decision Date | 2015-08-19 |
| Summary: | summary |