The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Nidek Model Vt-4000, Modification.
Device ID | K936302 |
510k Number | K936302 |
Device Name: | NIDEK MODEL VT-4000, MODIFICATION |
Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
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 | HQE |
CFR Regulation Number | 886.4150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-29 |
Decision Date | 1994-07-15 |