Device Classification Name |
orthosis, cranial
|
De Novo Number |
DEN980001 |
510(K) Number |
K964992
|
Device Name |
DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND |
Requester |
cranial technologies, inc. |
1331 north 7th st., suite 170 |
phoenix,
AZ
85006
|
|
Contact |
timothy r littlefield |
|
Regulation Number | 882.5970
|
Classification Product Code |
|
Date Received | 03/31/1998 |
Decision Date | 05/29/1998 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Neurology
|
Review Advisory Committee |
Neurology
|
Classification Order |
Classification Order
|
Type |
Post-NSE
|
|
|