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FDA 510(k) Application Details - K181019
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K181019
Device Name
Powered Laser Surgical Instrument
Applicant
Guangzhou Huafei Tongda Technology Co., Ltd.
4/F, Building B Industrial and Commercial Trading Park,
Hainan Town
Huadi Dadao Nan Road, Fangcun, Liwan Dis 510388 CN
Other 510(k) Applications for this Company
Contact
Liu Pengqi
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
04/17/2018
Decision Date
07/16/2018
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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