FDA 510(k) Application Details - K190278

Device Classification Name	System, Suction, Lipoplasty   More FDA Info for this Device
510(K) Number	K190278
Device Name	System, Suction, Lipoplasty
Applicant	AuraGen Aesthetics LLC 11 Dellbrook Road Weston, MA 02493 US Other 510(k) Applications for this Company
Contact	Yiannis Monovoukas Other 510(k) Applications for this Contact
Regulation Number	878.5040   More FDA Info for this Regulation Number
Classification Product Code	MUU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/08/2019
Decision Date	05/03/2019
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