FDA 510(k) Application Details - K121485

Device Classification Name	More FDA Info for this Device
510(K) Number	K121485
Device Name	GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING
Applicant	HEMCON MEDICAL TECHNOLOGIES EUROPE LTD 10575 SW CASCADE AVENUE SUITE 130 PORTLAND, OR 97223-4363 US Other 510(k) Applications for this Company
Contact	BARBARA MCGRATH Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/18/2012
Decision Date	08/21/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review