FDA 510(k) Application Details - K200751

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K200751
Device Name	Powered Laser Surgical Instrument
Applicant	Shangdong Huamei Technology Co., Ltd. No. 588, Changning Street, High-tech District Weifang 261205 CN Other 510(k) Applications for this Company
Contact	Xu QingHua 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	03/23/2020
Decision Date	05/21/2020
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