FDA 510(k) Application Details - K140558

Device Classification Name	More FDA Info for this Device
510(K) Number	K140558
Device Name	PROCTIGARD
Applicant	ACCESS PHARMACEUTICALS, INC 1325 AVENUE OF THE AMERICA, 27TH FLOOR NEW YORK, NY 10019 US Other 510(k) Applications for this Company
Contact	JEFFREY B DAVIS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/05/2014
Decision Date	07/16/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review