510(k) K946194
- Device
- WEE BAG O'MERCURY
- Applicant
- MICROSURGICAL TECHNOLOGY, INC.
- 510(k) number
- K946194
- Product code
- LCC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-02-27
- Date received
- 1994-12-20
- Regulation
- 886.4610
- Classification name
- Applicator, Ocular Pressure
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ISIDRO NILSSON
- Address
- 723-B 9th Ave. Kirkland WA US 98033 98033
FDA Registration Numbers#
- 2242450
- 3015177648
- 1926681
- 3005528784
- 3040602660
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LCC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K112952 | ILWAIT TIMER OCULOPRESSOR | Oryx Medical Pty, Ltd. | 2012-05-10 |
| 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#
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FDA Review#
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