FDA 510(k) Application Details - K981993

Device Classification Name	Endoscopic Central Control Unit   More FDA Info for this Device
510(K) Number	K981993
Device Name	Endoscopic Central Control Unit
Applicant	THE OLYMPUS OPTICAL CO. ENDOSCOPE DIVISION TWO CORPORATE CENTER DRIVE MELVILLE, NY 11747-3157 US Other 510(k) Applications for this Company
Contact	LAURA STORMS-TYLER Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	ODA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/08/1998
Decision Date	08/21/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review