510(k) K840004
- Device
- WEE BAG O'MERCURY
- Applicant
- SURGI-QUIP INC.U
- 510(k) number
- K840004
- Product code
- LCC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-03-22
- Date received
- 1984-01-04
- Regulation
- 886.4610
- Classification name
- Applicator, Ocular Pressure
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
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 |
| K946194 | WEE BAG O'MERCURY | Microsurgical Technology, Inc. | 1995-02-27 |
| K852032 | OCULAR PRESSURE REDUCER (MCCANNEL) | Visitec Co. | 1985-08-12 |
| 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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