Device Classification Name |
internal tissue marker
|
De Novo Number |
DEN130004 |
Device Name |
MOERAE SURGICAL MARKING PEN |
Requester |
moerae matrix, inc. |
675 us highway 1 |
north brunswick,
NJ
08902
|
|
Contact |
robert j chin |
|
Regulation Number | 878.4670
|
Classification Product Code |
|
Date Received | 05/06/2013 |
Decision Date | 12/18/2014 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
General & Plastic Surgery
|
Review Advisory Committee |
General & Plastic Surgery
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Post-NSE
|
|
|