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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, ultraviolet, dermatological
510(k) Number K200971
Device Name 308nm Excimer System
Applicant
Xuzhou Kernel Medical Equipment Co., Ltd.
Kernel Mansion, Economic Development District
Xuzhou,  CN 221004
Applicant Contact Jing Wang
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
RM.608,No.738,Shangcheng Rd.,Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number878.4630
Classification Product Code
FTC  
Date Received04/13/2020
Decision Date 12/15/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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