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510(k) K191571

UV Radiation Treatment System by Xuzhou Yongkang Electronic Science Technology Co., Ltd. — Product Code FTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2020
Date Received
June 14, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Ultraviolet, Dermatological
Device Class
Class II
Regulation Number
878.4630
Review Panel
SU
Submission Type

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