FDA 510(k) Application Details - K092562

Device Classification Name	Neurological Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K092562
Device Name	Neurological Stereotaxic Instrument
Applicant	FHC, INC. 1201 MAIN ST BOWDOIN, ME 04287 US Other 510(k) Applications for this Company
Contact	LEE D MARGOLIN 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	08/20/2009
Decision Date	09/18/2009
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