The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Multi Color Laser Photocoagulator, Model Mc-300.
Device ID | K042785 |
510k Number | K042785 |
Device Name: | MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300 |
Classification | Powered Laser Surgical Instrument |
Applicant | NIDEK, INC. 21911 ERIE LN. Lake Forest, CA 92630 |
Contact | Carol Patterson |
Correspondent | Carol Patterson NIDEK, INC. 21911 ERIE LN. Lake Forest, 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 | 2004-10-06 |
Decision Date | 2004-12-14 |
Summary: | summary |