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 |