The following data is part of a premarket notification filed by Xuzhou Kernel Medical Equipment Co., Ltd. with the FDA for Hair Growth System.
Device ID | K200929 |
510k Number | K200929 |
Device Name: | Hair Growth System |
Classification | Laser, Comb, Hair |
Applicant | Xuzhou Kernel Medical Equipment Co., Ltd. Kernel Mansion, Economic Development District Xuzhou, CN |
Contact | Wang Jing |
Correspondent | Jet Li Guangzhou KEDA Biological Tech Co., Ltd. 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou, CN |
Product Code | OAP |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-04-07 |
Decision Date | 2020-06-03 |