| Device Classification Name |
device, monitoring, intracranial pressure
|
|---|
| 510(K) Number |
K121159 |
|---|
| Device Name |
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER |
|---|
| Applicant |
| INTEGRA LIFESCIENCE CORPORTATION |
| 311 enterprise drive |
|
plainsboro,
NJ
08536
|
|
| Contact |
steven peltier |
| Regulation Number | 882.1620
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 04/16/2012 |
|---|
| Decision Date | 07/20/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Neurology
|
|---|
| Review Advisory Committee |
Ear Nose & Throat
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
