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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 K172273
Device Name 308nm Excimer System
Applicant
Chongqing Peninsula Medical Technology Co., Ltd.
#2-4, 2f Block I, Ke Yuan 4th Rd., Jiulongpo District
Chongqing,  CN 400041
Applicant Contact Zhang Sudi
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
Suite 306, Kecheng Mansion, #121 Science Rd., Guangzhou
Science Park
Guangzhou,  CN 510000
Correspondent Contact Cassie Lee
Regulation Number878.4630
Classification Product Code
FTC  
Date Received07/28/2017
Decision Date 07/30/2018
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
Predetermined Change
Control Plan Authorized		 No
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