FDA 510(k) Application Details - K153582

Device Classification Name	More FDA Info for this Device
510(K) Number	K153582
Device Name	Prometheus ChitoGauze XR PRO
Applicant	HEMCON MEDICAL TECHNOLOGIES, INC. 720 SW WASHINGTON STREET, SUITE 200 PORTLAND, OR 97205 US Other 510(k) Applications for this Company
Contact	Maire Ni Beilliu 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	12/15/2015
Decision Date	05/25/2016
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