| Device Classification Name |
light, surgical, ceiling mounted
|
| 510(K) Number |
K122875 |
| Device Name |
ORICARE L2700 |
| Applicant |
| ORICARE, INC. |
| 1900 am drive |
|
quakertown,
PA
18951
|
|
| Contact |
david t jamison |
| Regulation Number | 878.4580
|
| Classification Product Code |
|
| Date Received | 09/19/2012 |
| Decision Date | 12/18/2012 |
| Decision |
substantially equivalent (SE) |
| Classification Advisory Committee |
General & Plastic Surgery
|
| Review Advisory Committee |
General & Plastic Surgery
|
| summary |
summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Expedited Review |
No
|
| Combination Product |
No
|
|
|