The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Microkeratome, Model Mk-2000.
| Device ID | K990900 |
| 510k Number | K990900 |
| Device Name: | MICROKERATOME, MODEL MK-2000 |
| Classification | Keratome, Ac-powered |
| Applicant | NIDEK, INC. 47651 WESTINGHOUSE DR. Fremont, CA 94539 |
| Contact | Jerry Tsutsumi |
| Correspondent | Jerry Tsutsumi NIDEK, INC. 47651 WESTINGHOUSE DR. Fremont, CA 94539 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-18 |
| Decision Date | 1999-09-24 |
| Summary: | summary |