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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 K190685
Device Name Hair Growth System
Applicant
Xuzhou Kernel Medical Equipment Co., Ltd.
Kernel Mansion, Economic Development District
Xuzhou,  CN
Applicant Contact Wang Jing
Correspondent
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
OAP  
Date Received03/18/2019
Decision Date 07/26/2019
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
Predetermined Change
Control Plan Authorized		 No
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