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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laser, comb, hair
510(k) Number K200929
Device Name Hair Growth System
Xuzhou Kernel Medical Equipment Co., Ltd.
Kernel Mansion, Economic Development District
Xuzhou,  CN
Applicant Contact Wang Jing
Guangzhou KEDA Biological Tech Co., Ltd.
6F, No.1 TianTai road, Science City, LuoGang District
Guangzhou,  CN
Correspondent Contact Jet Li
Regulation Number890.5500
Classification Product Code
Date Received04/07/2020
Decision Date 06/03/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No