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 |