FDA 510(k) Application Details - K103054

Device Classification Name	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic   More FDA Info for this Device
510(K) Number	K103054
Device Name	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Applicant	IZUN PHARMACEUTICALS CORPORATION 420 LEXINGTON AVENUE NEW YORK, NY 10170 US Other 510(k) Applications for this Company
Contact	IRVING WIESEN Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MGQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/2010
Decision Date	02/07/2011
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