The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Model Dc-1200 Diode Laser Photocoagulator.
| Device ID | K895196 |
| 510k Number | K895196 |
| Device Name: | MODEL DC-1200 DIODE LASER PHOTOCOAGULATOR |
| Classification | Laser, Ophthalmic |
| Applicant | NIDEK, INC. CRC ASSOCIATES 25422 TRABUCO ROAD#105-253 El Toro, CA 92630 |
| Contact | Mccomb, Ph.d. |
| Correspondent | Mccomb, Ph.d. NIDEK, INC. CRC ASSOCIATES 25422 TRABUCO ROAD#105-253 El Toro, CA 92630 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-11 |
| Decision Date | 1989-10-16 |