Device Classification Name |
pressure wedge, perianal, for reduction of cesarean delivery
|
De Novo Number |
DEN160005 |
Device Name |
Hem-Avert Perianal Stabilizer |
Requester |
stetrix, inc. |
70 clay st |
oakland,
TN
38060
|
|
Contact |
mark buchanan |
|
Regulation Number | 884.5210
|
Classification Product Code |
|
Date Received | 01/28/2016 |
Decision Date | 12/19/2016 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Obstetrics/Gynecology
|
Review Advisory Committee |
Obstetrics/Gynecology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|