FDA 510(k) Application Details - K192521

Device Classification Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect   More FDA Info for this Device
510(K) Number	K192521
Device Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
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	ONF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/13/2019
Decision Date	12/06/2019
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