Device Classification Name |
negative pressure wound therapy device for reduction of wound complications
|
De Novo Number |
DEN180013 |
Device Name |
PREVENA 125 and PREVENA PLUS 125 Therapy Units |
Requester |
kci usa, inc. |
6203 farinon drive |
san antonio,
TX
78249
|
|
Contact |
kimberly mccoy |
|
Regulation Number | 878.4783
|
Classification Product Code |
|
Date Received | 03/15/2018 |
Decision Date | 04/19/2019 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
General & Plastic Surgery
|
Review Advisory Committee |
General & Plastic Surgery
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|