FDA 510(k) Application Details - K161247

Device Classification Name	More FDA Info for this Device
510(K) Number	K161247
Device Name	Relizorb
Applicant	Alcresta Therapeutics, Inc. One Newton Executive Park, Suite 102 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	05/03/2016
Decision Date	06/30/2016
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