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FDA 510(k) Application Details - K202980
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K202980
Device Name
Powered Laser Surgical Instrument
Applicant
Shenzhen Leaflife Technology Co., Ltd
Bldg. C, JMD Industrial Park, No.39 Qingfeng Blvd.,
Baolong Industrial Area, Longgang District
Shenzhen 518116 CN
Other 510(k) Applications for this Company
Contact
Cheng Qiang
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
09/30/2020
Decision Date
11/19/2020
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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