FDA 510(k) Application Details - K122740

Device Classification Name	Endoscopic Irrigation/Suction System   More FDA Info for this Device
510(K) Number	K122740
Device Name	Endoscopic Irrigation/Suction System
Applicant	JETPREP, LTD. COLUMBIA SQUARE 555 13TH STREET, NW WASHINGTON, DC 20004 US Other 510(k) Applications for this Company
Contact	JOHN SMITH, MD, JD Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	OCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/06/2012
Decision Date	12/10/2012
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