The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Nidek/phaco Emulsification System Model Cv-8000.
| Device ID | K901686 |
| 510k Number | K901686 |
| Device Name: | NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000 |
| Classification | Unit, Phacofragmentation |
| 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 | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-12 |
| Decision Date | 1990-06-08 |