The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Nidek, Inc. Bio-dc Laser Delivery System.
Device ID | K900165 |
510k Number | K900165 |
Device Name: | NIDEK, INC. BIO-DC LASER DELIVERY SYSTEM |
Classification | Powered Laser Surgical Instrument |
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 | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-12 |
Decision Date | 1990-03-22 |