FDA 510(k) Application Details - K080547

Device Classification Name	Neurological Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K080547
Device Name	Neurological Stereotaxic Instrument
Applicant	AESCULAP IMPLANT SYSTEM, INC. 3773 Corporate Parkway 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	882.4560   More FDA Info for this Regulation Number
Classification Product Code	HAW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/28/2008
Decision Date	05/23/2008
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