The following data is part of a premarket notification filed by Integra Lifescience Corportation with the FDA for Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit With Intrgra Camino Flex Adapter.
| Device ID | K121159 |
| 510k Number | K121159 |
| Device Name: | INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | INTEGRA LIFESCIENCE CORPORTATION 311 ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| Contact | Steven Peltier |
| Correspondent | Steven Peltier INTEGRA LIFESCIENCE CORPORTATION 311 ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-16 |
| Decision Date | 2012-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780040965 | K121159 | 000 |
| 10381780122012 | K121159 | 000 |
| M273FLEXEXT1 | K121159 | 000 |