FDA 510(k) Application Details - K232632

Device Classification Name	Generator, Lesion, Radiofrequency   More FDA Info for this Device
510(K) Number	K232632
Device Name	Generator, Lesion, Radiofrequency
Applicant	Epimed International 141 Sal Landrio Dr. Crossroads Business Park Johnstown, NY 12095 US Other 510(k) Applications for this Company
Contact	Preston Frasier 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	08/30/2023
Decision Date	05/24/2024
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