The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Nidek Dc-3000 Diode Laser Photocoagulator.
Device ID | K903639 |
510k Number | K903639 |
Device Name: | NIDEK DC-3000 DIODE LASER PHOTOCOAGULATOR |
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 | 1990-08-13 |
Decision Date | 1991-02-04 |