FDA 510(k) Application Details - K200030

Device Classification Name	Device, Neurovascular Embolization   More FDA Info for this Device
510(K) Number	K200030
Device Name	Device, Neurovascular Embolization
Applicant	Balt USA, LLC 29 Parker Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Michael Peters Other 510(k) Applications for this Contact
Regulation Number	882.5950   More FDA Info for this Regulation Number
Classification Product Code	HCG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/07/2020
Decision Date	02/01/2020
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