FDA 510(k) Application Details - K063786

Device Classification Name	Insufflator, Automatic Carbon-Dioxide For Endoscope   More FDA Info for this Device
510(K) Number	K063786
Device Name	Insufflator, Automatic Carbon-Dioxide For Endoscope
Applicant	OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 CENTER VALLEY, PA 18034-0610 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	FCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2006
Decision Date	03/05/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review