The following data is part of a premarket notification filed by Ezgo Group Inc. with the FDA for Led Curing Light.
Device ID | K192009 |
510k Number | K192009 |
Device Name: | LED Curing Light |
Classification | Activator, Ultraviolet, For Polymerization |
Applicant | EZGO Group Inc. 8840 Flower Rd 120 Rancho Cucamonga, CA 91730 |
Contact | Hong Chen |
Correspondent | Jet Li Guangzhou KEDA Biological Tech Co., Ltd. 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou, CN |
Product Code | EBZ |
CFR Regulation Number | 872.6070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-07-29 |
Decision Date | 2020-01-09 |