FDA 510(k) Application Details - K201610

Device Classification Name	Generator, Lesion, Radiofrequency   More FDA Info for this Device
510(K) Number	K201610
Device Name	Generator, Lesion, Radiofrequency
Applicant	Abbott Medical 5050 Nathan Lane Plymouth, MN 55442 US Other 510(k) Applications for this Company
Contact	Jim Chapman Other 510(k) Applications for this Contact
Regulation Number	882.4400   More FDA Info for this Regulation Number
Classification Product Code	GXD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/15/2020
Decision Date	10/21/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review