The following data is part of a premarket notification filed by Oryx Medical Pty Ltd with the FDA for Ilwait Timer Oculopressor.
| Device ID | K112952 |
| 510k Number | K112952 |
| Device Name: | ILWAIT TIMER OCULOPRESSOR |
| Classification | Applicator, Ocular Pressure |
| Applicant | ORYX MEDICAL PTY LTD UNIT 4/43 CALEDONIAN AVENUE Maylands, AT 6051 |
| Contact | Anne F Jones |
| Correspondent | Anne F Jones ORYX MEDICAL PTY LTD UNIT 4/43 CALEDONIAN AVENUE Maylands, AT 6051 |
| Product Code | LCC |
| CFR Regulation Number | 886.4610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-05 |
| Decision Date | 2012-05-10 |
| Summary: | summary |