510(k) K112952
- Device
- ILWAIT TIMER OCULOPRESSOR
- Applicant
- ORYX MEDICAL PTY LTD
- 510(k) number
- K112952
- Product code
- LCC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-05-10
- Date received
- 2011-10-05
- Regulation
- 886.4610
- Classification name
- Applicator, Ocular Pressure
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANNE F JONES
- Address
- Unit 4/43 Caledonian Ave. Maylands AT 6051 6051
FDA Registration Numbers#
- 2242450
- 3015177648
- 1926681
- 3005528784
- 3040602660
Source Documents#
Other 510(k) Records For Product Code LCC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K946194 | WEE BAG O'MERCURY | Microsurgical Technology, Inc. | 1995-02-27 |
| K852032 | OCULAR PRESSURE REDUCER (MCCANNEL) | Visitec Co. | 1985-08-12 |
| K840004 | WEE BAG O'MERCURY | Surgi-Quip Inc.U | 1984-03-22 |
| K820526 | RELIEF VALVE-HONAN INTRAOC. PRESSURE | The Lebanon Corp. | 1982-03-25 |
| K792255 | NEVYAS AUTOPRESS EYE COMPRESSOR | Keeler Optical Products , Ltd. | 1979-12-11 |
Legacy Summary#
summary
FDA Review#
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