FDA 510(k) Application Details - K161991

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K161991
Device Name	Dressing, Wound, Drug
Applicant	IZUN PHARMACEUTICALS ONE ROCKEFELLER PLAZA, 11TH FLOOR NEW YORK, NY 10020 US Other 510(k) Applications for this Company
Contact	JACK TALLEY Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	FRO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/19/2016
Decision Date	03/03/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review