The following data is part of a premarket notification filed by The O R Company Pty Ltd with the FDA for Dumi Manipulator.
| Device ID | K212505 |
| 510k Number | K212505 |
| Device Name: | DUMI ManipulatOR |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | The O R Company Pty Ltd 1/32 Silkwood Place Carrum Downs, AU 3201 |
| Contact | Amesha Silva |
| Correspondent | Amesha Silva The O R Company Pty Ltd 1/32 Silkwood Place Carrum Downs, AU 3201 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-09 |
| Decision Date | 2022-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09349967001035 | K212505 | 000 |