FDA 510(k) Application Details - K133729

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K133729
Device Name	Dressing, Wound, Drug
Applicant	MANUKA HEALTH NEW ZEALAND LTD. 1011 U.S. HIGHWAY 22 SUITE 200 BRIDGEWATER, NJ 08807-2950 US Other 510(k) Applications for this Company
Contact	DAVID BECHTEL 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	12/06/2013
Decision Date	01/23/2015
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