FDA 510(k) Application Details - K073576

Device Classification Name	Neurosurgical Paddie   More FDA Info for this Device
510(K) Number	K073576
Device Name	Neurosurgical Paddie
Applicant	HAROD ENTERPRISES, INC. 4052 INDIAN CREEK ROAD MARTINEZ, GA 30907 US Other 510(k) Applications for this Company
Contact	NORRIS R HAROD 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	12/19/2007
Decision Date	02/22/2008
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