CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C

Device, Monitoring, Intracranial Pressure

INTEGRA LIFESCIENCES CORPORATION

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.

Pre-market Notification Details

Device IDK102875
510k NumberK102875
Device Name:CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C
ClassificationDevice, Monitoring, Intracranial Pressure
Applicant INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro,  NJ  08536
ContactDonna Millisky
CorrespondentDonna Millisky
INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro,  NJ  08536
Product CodeGWM  
CFR Regulation Number882.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-10-01
Decision Date2010-12-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10381780023661 K102875 000
10381780025511 K102875 000
10381780023630 K102875 000
10381780023623 K102875 000

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