FDA 510(k) Application Details - DEN130047

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN130047
Device Name	PROLONG
Applicant	ERGON MEDICAL LTD. 25 BARKER CLOSE FISHBOURNE, CHICHESTER WEST SUSSEX PO18 8BJ GB Other 510(k) Applications for this Company
Contact	BARRY PEARCE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/2013
Decision Date	03/20/2015
Decision	DENG -
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review