FDA 510(k) Application Details - K210993

Device Classification Name	Device, Monitoring, Intracranial Pressure   More FDA Info for this Device
510(K) Number	K210993
Device Name	Device, Monitoring, Intracranial Pressure
Applicant	Integra LifeSciences Production Corporation 11 Cabot Boulevard Mansfield, MA 02048 US Other 510(k) Applications for this Company
Contact	MaryBeth Carson Other 510(k) Applications for this Contact
Regulation Number	882.1620   More FDA Info for this Regulation Number
Classification Product Code	GWM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/02/2021
Decision Date	04/30/2021
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