FDA 510(k) Application Details - K963642

Device Classification Name	Endoscope, Neurological   More FDA Info for this Device
510(K) Number	K963642
Device Name	Endoscope, Neurological
Applicant	SOFAMOR DANEK USA,INC. 1800 PYRAMID PLACE MEMPHIS, TN 38132 US Other 510(k) Applications for this Company
Contact	RICHARD W TREHARNE Other 510(k) Applications for this Contact
Regulation Number	882.1480   More FDA Info for this Regulation Number
Classification Product Code	GWG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/12/1996
Decision Date	03/18/1998
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