FDA 510(k) Application Details - K112106

Device Classification Name	Endoscope Channel Accessory   More FDA Info for this Device
510(K) Number	K112106
Device Name	Endoscope Channel Accessory
Applicant	SMART MEDICAL SYSTEMS, LTD. 10 HAYETSIRA STREET RAANANA 43663 IL Other 510(k) Applications for this Company
Contact	ADVA YOSELZON Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	ODC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/22/2011
Decision Date	02/06/2012
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