FDA 510(k) Application Details - K131096

Device Classification Name	Wound Cleaner, Ultrasound   More FDA Info for this Device
510(K) Number	K131096
Device Name	Wound Cleaner, Ultrasound
Applicant	AROBELLA MEDICAL, LLC 5929 BAKER ROAD SUITE 470 MINNETONKA, MN 55345 US Other 510(k) Applications for this Company
Contact	MATTHEW BERSCHEID Other 510(k) Applications for this Contact
Regulation Number	878.4410   More FDA Info for this Regulation Number
Classification Product Code	NRB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/18/2013
Decision Date	05/16/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review