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 |