FDA 510(k) Application Details - K123704

Device Classification Name	More FDA Info for this Device
510(K) Number	K123704
Device Name	AUTOMATED ENDOSCOPE LEAK TESTER
Applicant	OLYMPUS MEDICAL SYSTEMS CORP. REGULATORY AFFAIRS & QUALITY ASSURANCE 3500 CORPORATE PARKWAY CENTER VALLEY, PA 18034-0610 US Other 510(k) Applications for this Company
Contact	DAPHNEY GERMAIN-KOLAWOLE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/03/2012
Decision Date	02/04/2013
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