Device Classification Name |
cutaneous tissue adhesive with mesh
|
De Novo Number |
DEN090005 |
510(K) Number |
K082289
|
Device Name |
PRINEO SKIN CLOSURE SYSTEM |
Requester |
closure medical corp. |
5250 greens dairy rd. |
raleigh,
NC
27616
|
|
Contact |
bruce krattenmaker |
|
Regulation Number | 878.4011
|
Classification Product Code |
|
Date Received | 03/24/2009 |
Decision Date | 04/30/2010 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
General & Plastic Surgery
|
Review Advisory Committee |
General & Plastic Surgery
|
Classification Order |
Classification Order
|
Type |
Post-NSE
|