The following data is part of a premarket notification filed by Nova/da Vinci Systems, Inc. with the FDA for Nova Cordless Curing Light.
Device ID | K000393 |
510k Number | K000393 |
Device Name: | NOVA CORDLESS CURING LIGHT |
Classification | Activator, Ultraviolet, For Polymerization |
Applicant | NOVA/DA VINCI SYSTEMS, INC. 9885 MESA RIM SUITE 127 San Diego, CA 92121 |
Contact | Alan A Creamer |
Correspondent | Alan A Creamer NOVA/DA VINCI SYSTEMS, INC. 9885 MESA RIM SUITE 127 San Diego, CA 92121 |
Product Code | EBZ |
CFR Regulation Number | 872.6070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-02-07 |
Decision Date | 2000-03-27 |