FDA 510(k) Application Details - K173763

Device Classification Name	Device, Surgical, Cryogenic   More FDA Info for this Device
510(K) Number	K173763
Device Name	Device, Surgical, Cryogenic
Applicant	Myoscience, Inc 46400 Fremont Blvd Fremont, CA 94538 US Other 510(k) Applications for this Company
Contact	Kent Jones Other 510(k) Applications for this Contact
Regulation Number	882.4250   More FDA Info for this Regulation Number
Classification Product Code	GXH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/2017
Decision Date	02/28/2018
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