FDA 510(k) Application Details - K002765

Device Classification Name	Device, Monitoring, Intracranial Pressure   More FDA Info for this Device
510(K) Number	K002765
Device Name	Device, Monitoring, Intracranial Pressure
Applicant	INTEGRA NEUROSCIENCES 5955 PACIFIC CENTER BLVD. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	NANCY MATHEWSON 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	09/05/2000
Decision Date	11/24/2000
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