Device Classification Name |
wound retraction and protection system
|
De Novo Number |
DEN150038 |
Device Name |
CleanCisionTM Wound Retraction and Protection System |
Requester |
prescient surgical |
1585 industrial road |
san carlos,
CA
94070
|
|
Contact |
lisa ruehlow |
|
Regulation Number | 878.4371
|
Classification Product Code |
|
Date Received | 08/13/2015 |
Decision Date | 12/16/2016 |
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
|