LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT

Device, Monitoring, Intracranial Pressure

INTEGRA LIFESCIENCES CORP.

The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Licox It2 Complete Brain Tunneling Probe Kit.

Pre-market Notification Details

Device IDK053244
510k NumberK053244
Device Name:LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT
ClassificationDevice, Monitoring, Intracranial Pressure
Applicant INTEGRA LIFESCIENCES CORP. 311C ENTERPRISE DRIVE Plainsboro,  NJ  08536
ContactJon Caparotta
CorrespondentJon Caparotta
INTEGRA LIFESCIENCES CORP. 311C ENTERPRISE DRIVE Plainsboro,  NJ  08536
Product CodeGWM  
CFR Regulation Number882.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-11-21
Decision Date2006-05-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M272IT21 K053244 000
M273IT21 K053244 000

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