FDA 510(k) Application Details - K971340

Device Classification Name	Endoscope, Neurological   More FDA Info for this Device
510(K) Number	K971340
Device Name	Endoscope, Neurological
Applicant	OLYMPUS OPTICAL, CO. 55 NORTHERN BLVD., SUITE 410 GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	SUSAN D GOLDSTEIN-FALK 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	04/10/1997
Decision Date	07/29/1998
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