510(k) K961805
- Device
- TOMEY DTL ELECTRODE
- Applicant
- TOMEY CORPORATION USA
- 510(k) number
- K961805
- Product code
- HLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-05-09
- Date received
- 1996-05-10
- Regulation
- 886.1220
- Classification name
- Electrode, Corneal
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SUSUMU NOZAWA
- Address
- 325 Vassar St. 2nd Floor Cambridge MA US 02139 02139
FDA Registration Numbers#
- 3033274216
- 8043792
- 1221363
- 3004072823
- 2183828
Source Documents#
Other 510(k) Records For Product Code HLZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253586 | RM Electrode (RMH 25-01) | Retmap, Inc. | 2026-04-01 |
| K232273 | RM Electrode (RMH 23-01) | Retmap, Inc. | 2023-12-07 |
| K926540 | SOPHER AND BIERER OVUM FORCEPS | Thomasville Medical Assoc. | 1994-02-25 |
| K913239 | GOLDLENS(TM) | Doran Instruments, Inc. | 1992-01-31 |
| K844409 | DTL ELECTRODE | Sauquoit Industries, Inc. | 1985-02-14 |
| K830557 | ERG-JET ELECTRODE | Universo S.A. | 1983-03-31 |
| K820254 | GOLD FOIL ERG ELECTRODES | Cadwell Laboratories, Inc. | 1982-04-09 |
| K813399 | ERG-JET ELECTRODE | Nicolet Biomedical Instruments | 1982-01-22 |
| K781476 | MULAR GOLD LEAF ELECTRODE MODEL 7501 | Life-Tech Instruments, Inc. | 1978-11-15 |
| K760199 | ELECTRORETINOGRAPH | Lkc Technologies, Inc. | 1976-08-04 |
Legacy Summary#
summary
FDA Review#
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