FDA 510(k) Application Details - K163615

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K163615
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	CareFusion 2200 Inc 75 North Fairway Drive Vernon Hills, IL 60061 US Other 510(k) Applications for this Company
Contact	Jane Weber 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	12/22/2016
Decision Date	05/04/2017
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