FDA 510(k) Application Details - K043223

Device Classification Name	Neurological Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K043223
Device Name	Neurological Stereotaxic Instrument
Applicant	DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. WARSAW, IN 46581-0988 US Other 510(k) Applications for this Company
Contact	RANDA FRANKLIN 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	11/22/2004
Decision Date	03/04/2005
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