FDA 510(k) Application Details - K143634

Device Classification Name	Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)   More FDA Info for this Device
510(K) Number	K143634
Device Name	Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Applicant	MEDIGUS LTD. BUILDING 7A, OMER IMDUSTRIAL PARK OMER 84965 IL Other 510(k) Applications for this Company
Contact	SHARON KANETY DERESH Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	ODE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2014
Decision Date	01/20/2015
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