FDA 510(k) Application Details - K163442

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K163442
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	Modern Medical Equipment Manufacturing Limited 35-41 Tai Lin Pai Rd, Unit F 5th Fl, Gold King Ind., Bldg., Kwai Chung, N.T. Hong Kong CN Other 510(k) Applications for this Company
Contact	Thomas Tsz Fung Chan Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	GEI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/08/2016
Decision Date	09/28/2017
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