FDA 510(k) Application Details - DEN180013

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN180013
Device Name	PREVENA 125 and PREVENA PLUS 125 Therapy Units
Applicant	KCI USA, Inc. 6203 Farinon Drive San Antonio, TX 78249 US Other 510(k) Applications for this Company
Contact	Kimberly McCoy Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QFC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/15/2018
Decision Date	04/19/2019
Decision	DENG -
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review