Device Classification Name |
dermal cooling pack/vacuum/massager
|
De Novo Number |
DEN090002 |
510(K) Number |
K080521
|
Device Name |
ZELTIQ AESTHETICS DERMAL COOLING DEVICE |
Requester |
zeltiq aesthetics |
4698 willow road |
pleasanton,
CA
94588
|
|
Contact |
louis-pierre marcoux |
|
Regulation Number | 878.4340
|
Classification Product Code |
|
Date Received | 10/13/2009 |
Decision Date | 08/24/2010 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
General & Plastic Surgery
|
Review Advisory Committee |
General & Plastic Surgery
|
Classification Order |
Classification Order
|
Type |
Post-NSE
|