FDA 510(k) Application Details - DEN150001

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN150001
Device Name	RELIZORB
Applicant	ALCRESTA, INC. ONE NEWTON EXECUTIVE PARK, SUITE 202 NEWTON, MA 02462 US Other 510(k) Applications for this Company
Contact	ROBERT GALLOTTO Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/2015
Decision Date	11/20/2015
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