FDA 510(k) Application Details - K150916

Device Classification Name	More FDA Info for this Device
510(K) Number	K150916
Device Name	HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO
Applicant	HemCon Medical Technologies, Inc. 720 SW Washington Street, Suite 200 Portland, OR 97225 US Other 510(k) Applications for this Company
Contact	Jody Oyama 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	04/06/2015
Decision Date	11/10/2015
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