The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Nidek Model Adc-8000.
| Device ID | K894709 |
| 510k Number | K894709 |
| Device Name: | NIDEK MODEL ADC-8000 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | NIDEK, INC. 2460 EMBARCADERO WAY P.O.BOX 50488 Palo Alto, CA 94303 |
| Contact | Ken Kato |
| Correspondent | Ken Kato NIDEK, INC. 2460 EMBARCADERO WAY P.O.BOX 50488 Palo Alto, CA 94303 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-24 |
| Decision Date | 1989-10-04 |