FDA 510(k) Application Details - K182565

Device Classification Name	Device, Surgical, Cryogenic   More FDA Info for this Device
510(K) Number	K182565
Device Name	Device, Surgical, Cryogenic
Applicant	AtriCure, Inc. 7555 Innovation Way Mason, OH 45040 US Other 510(k) Applications for this Company
Contact	Jonathan McElwee 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	09/18/2018
Decision Date	11/09/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review