FDA 510(k) Application Details - K051613

Device Classification Name	Endoscopic Central Control Unit   More FDA Info for this Device
510(K) Number	K051613
Device Name	Endoscopic Central Control Unit
Applicant	OLYMPUS MEDICAL SYSTEMS CORPORATION TWO CORPORATE CENTER DR. MELVILLE, NY 11747-9058 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	06/17/2005
Decision Date	08/15/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review