FDA 510(k) Application Details - K202827

Device Classification Name Light, Ultraviolet, Dermatological

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510(K) Number K202827
Device Name Light, Ultraviolet, Dermatological
Applicant Shenzhen GSD Tech Co., Ltd.
Building A, JUNSD Hi-Tech Park, West of BaoÆAn RD.
Watch & Clock Base, Guangming District
Shenzhen 518106 CN
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Contact Zoe Yao
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Regulation Number 878.4630

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Classification Product Code FTC
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Date Received 09/24/2020
Decision Date 12/15/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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