The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Nidek Inc. Model Ac-2000 Derm.
Device ID | K904402 |
510k Number | K904402 |
Device Name: | NIDEK INC. MODEL AC-2000 DERM |
Classification | Powered Laser Surgical Instrument |
Applicant | NIDEK, INC. CRC ASSOCIATES 25422 TRABUCO ROAD#105-253 El Toro, CA 92630 |
Contact | Janet Mccomb |
Correspondent | Janet Mccomb NIDEK, INC. CRC ASSOCIATES 25422 TRABUCO ROAD#105-253 El Toro, CA 92630 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-09-25 |
Decision Date | 1990-12-07 |