FDA 510(k) Application Details - K031008

Device Classification Name	Neurosurgical Paddie   More FDA Info for this Device
510(K) Number	K031008
Device Name	Neurosurgical Paddie
Applicant	AESCULAP 3773 CORPORATE PKWY. CENTER VALLEY, PA 18034 US Other 510(k) Applications for this Company
Contact	MATTHEW M HULL Other 510(k) Applications for this Contact
Regulation Number	882.4700   More FDA Info for this Regulation Number
Classification Product Code	HBA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/31/2003
Decision Date	05/09/2003
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	Y
Expedited Review