The following data is part of a premarket notification filed by Kowa Optimed, Inc. with the FDA for Laser Flare Cell Meter Fc-1000.
| Device ID | K880920 |
| 510k Number | K880920 |
| Device Name: | LASER FLARE CELL METER FC-1000 |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | KOWA OPTIMED, INC. 20001 SOUTH VERMONT AVE. Torrance, CA 90502 |
| Contact | Hiroshi Okada |
| Correspondent | Hiroshi Okada KOWA OPTIMED, INC. 20001 SOUTH VERMONT AVE. Torrance, CA 90502 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-04 |
| Decision Date | 1988-09-27 |