FDA 510(k) Application Details - K191701

Device Classification Name	Holder, Head, Neurosurgical (Skull Clamp)   More FDA Info for this Device
510(K) Number	K191701
Device Name	Holder, Head, Neurosurgical (Skull Clamp)
Applicant	MRI Interventions, Inc. 5 Musick Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Pete Piferi Other 510(k) Applications for this Contact
Regulation Number	882.4460   More FDA Info for this Regulation Number
Classification Product Code	HBL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/25/2019
Decision Date	11/15/2019
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