FDA 510(k) Application Details - K160366

Device Classification Name	Electrosurgical Patient Return Electrode   More FDA Info for this Device
510(K) Number	K160366
Device Name	Electrosurgical Patient Return Electrode
Applicant	TOP-RANK Health Care Co., Ltd Checun Village, Dongguan Street, Shangyu District Shaoxing 312352 CN Other 510(k) Applications for this Company
Contact	Liubo Shen Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	ODR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/09/2016
Decision Date	08/19/2016
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