The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Nidek Model Gyc-1500 And Gyc-2000.
Device ID | K951079 |
510k Number | K951079 |
Device Name: | NIDEK MODEL GYC-1500 AND GYC-2000 |
Classification | Laser, Ophthalmic |
Applicant | NIDEK, INC. 47651 WESTINGHOUSE DR. Fremont, CA 94539 |
Contact | Ken Kato |
Correspondent | Ken Kato NIDEK, INC. 47651 WESTINGHOUSE DR. Fremont, CA 94539 |
Product Code | HQF |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-09 |
Decision Date | 1995-09-14 |