Device Classification Name |
system, documentation, breast lesion
|
De Novo Number |
DEN020001 |
510(K) Number |
K010514
|
Device Name |
BREASTVIEW VISUAL MAPPING SYSTEM |
Requester |
assurance medical |
555 thirteenth street, n.w. |
washington,
DC
20004 -1109
|
|
Contact |
howard m holstein |
|
Regulation Number | 884.2990
|
Classification Product Code |
|
Date Received | 05/28/2002 |
Decision Date | 01/31/2003 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Obstetrics/Gynecology
|
Review Advisory Committee |
Obstetrics/Gynecology
|
Type |
Post-NSE
|
|
|