FDA 510(k) Application Details - K052840

Device Classification Name	Neurological Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K052840
Device Name	Neurological Stereotaxic Instrument
Applicant	DENX ADVANCED DENTAL SYSTEMS MOSHAV ORA 106 JERUSALEM, AL 90880 IL Other 510(k) Applications for this Company
Contact	RACHEL WEISSBROD 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	10/07/2005
Decision Date	12/16/2005
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	Y
Expedited Review