FDA 510(k) Application Details - K172324

Device Classification Name	More FDA Info for this Device
510(K) Number	K172324
Device Name	Axiostat Chitosan Hemostatic Dressing
Applicant	Advamedica Inc. 485 Massachusetts Avenue, Suite 300, Cambridge, MA 02139 US Other 510(k) Applications for this Company
Contact	Leo Mavely 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	08/01/2017
Decision Date	02/23/2018
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