The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Camino 110-4b Olm Intracranial Pressure Mnitoring Kit; Camino 110-4g Post Craniotomy Subdural Pressure Monitoring Kit; C.
| Device ID | K102875 |
| 510k Number | K102875 |
| Device Name: | CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Donna Millisky |
| Correspondent | Donna Millisky INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. 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 | 2010-10-01 |
| Decision Date | 2010-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780023661 | K102875 | 000 |
| 10381780025511 | K102875 | 000 |
| 10381780023630 | K102875 | 000 |
| 10381780023623 | K102875 | 000 |