510(k) K843957
- Device
- ULTRATHIN/SP LENS
- Applicant
- OPTICAL SYSTEMS INTL., INC.
- 510(k) number
- K843957
- Product code
- HRG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-07-31
- Date received
- 1984-10-10
- Regulation
- 886.4070
- Classification name
- Engine, Trephine, Accessories, Ac-powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- EDWARD DERAJAS
- Address
- 1652 W. 32nd. Pl. Hialeah FL US 33012 33012
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HRG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K013151 | ASMOTOM AUTOMATED TREPHINE SYSTEM | Bkg Opthalmics USA, Inc. | 2001-12-14 |
| K981063 | AUTOMATED CORNEAL TREPHINE | Laser Center Dev. Corp. | 1998-06-23 |
| K841515 | SCANLAN VASCU-STATT II | Scanlan Intl., Inc. | 1984-06-05 |
| K823901 | TREPHINE BLADES-VARIOUS MODELS | Edward Weck, Inc. | 1983-01-17 |
| K791763 | (MICRO-KERATRON, MICRO DUCT TREPHINE) | Intl. Ophthalmic Industries Corp. | 1979-11-05 |
Legacy Summary#
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FDA Review#
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