FDA 510(k) Applications for Medical Device Product Code: NRB (Wound Cleaner, Ultrasound)

FDA 510(k) Applications for Medical Device Product Code "NRB"
(Wound Cleaner, Ultrasound)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K162721	ALLIQUA BIOMEDICAL, INC.	Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator	12/22/2016
K131096	AROBELLA MEDICAL, LLC	AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM	05/16/2014
K091038	AROBELLA MEDICAL, LLC	AS 1000 ULTRASOUND WOUND THERAPY SYSTEM	06/19/2009
DEN040004	CELLERATION	CELLERATION MIST THERAPY SYSTEM	06/25/2004
K050129	CELLERATION, INC.	CELLERATION MIST THERAPY SYSTEM 5.1	05/17/2005
K122246	CELLERATION, INC.	MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12	08/13/2012
K140782	CELLERATION, INC.	ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR	08/13/2014
K112782	MISONIX, INC.	MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES	12/01/2011
K123980	MISONIX, INC.	SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES	03/05/2013