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FDA 510(k) Application Details - K180353
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K180353
Device Name
Powered Laser Surgical Instrument
Applicant
Zhengzhou PZ Laser Slim Technology Co., Ltd
Fl 2th, jia Tu zhi ye
Intersection of Hong Song road and lian Hua road
High-tech Development Zone, Zhengzhou 450001 CN
Other 510(k) Applications for this Company
Contact
Zhou Hongwei
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
02/08/2018
Decision Date
04/17/2018
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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