FDA 510(k) Application Details - K162721

Device Classification Name	Wound Cleaner, Ultrasound   More FDA Info for this Device
510(K) Number	K162721
Device Name	Wound Cleaner, Ultrasound
Applicant	ALLIQUA BIOMEDICAL, INC. 11495 VALLEY VIEW ROAD EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	KATHY SIMPSON 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	09/29/2016
Decision Date	12/22/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review