FDA 510(k) Application Details - K121573

Device Classification Name	Device, Monitoring, Intracranial Pressure   More FDA Info for this Device
510(K) Number	K121573
Device Name	Device, Monitoring, Intracranial Pressure
Applicant	INTRGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DRIVE PLAINSBORO, NJ 08536 US Other 510(k) Applications for this Company
Contact	Erin Doyle 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	05/29/2012
Decision Date	09/10/2012
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