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FDA 510(k) Application Details - K210168
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K210168
Device Name
Powered Laser Surgical Instrument
Applicant
Beijing Kes Biology Technology CO., LTD.
PingguyuanZhongguancun Science And Technology Park,
Pinggu District
Beijing 101204 CN
Other 510(k) Applications for this Company
Contact
Wei Meng Meng
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
GEX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/22/2021
Decision Date
05/10/2021
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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