Device Classification Name |
dynamic rectal control system
|
De Novo Number |
DEN140020 |
Device Name |
ECLIPSE SYSTEM |
Requester |
pelvalon |
1171 barroilhet drive |
hillsborough,
CA
94010
|
|
Contact |
cindy domecus |
|
Regulation Number | 876.5930
|
Classification Product Code |
|
Date Received | 06/24/2014 |
Decision Date | 02/12/2015 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Gastroenterology/Urology
|
Review Advisory Committee |
Gastroenterology/Urology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
Expedited Review |
Yes
|
|
|