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FDA 510(k) Application Details - K200971
Device Classification Name
Light, Ultraviolet, Dermatological
More FDA Info for this Device
510(K) Number
K200971
Device Name
Light, Ultraviolet, Dermatological
Applicant
Xuzhou Kernel Medical Equipment Co., Ltd.
Kernel Mansion, Economic Development District
Xuzhou 221004 CN
Other 510(k) Applications for this Company
Contact
Jing Wang
Other 510(k) Applications for this Contact
Regulation Number
878.4630
More FDA Info for this Regulation Number
Classification Product Code
FTC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/13/2020
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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