OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM

Shunt, Central Nervous System And Components

INTEGRA LIFESCIENCES CORP.

The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Osv Ii Lumbar Valve System And Osv Ii Low Flow Lumbar Valve System.

Pre-market Notification Details

Device IDK092395
510k NumberK092395
Device Name:OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM
ClassificationShunt, Central Nervous System And Components
Applicant INTEGRA LIFESCIENCES CORP. 311 ENTERPRISE DR. Plainsboro,  NJ  08536
ContactDonna Millisky
CorrespondentDonna Millisky
INTEGRA LIFESCIENCES CORP. 311 ENTERPRISE DR. Plainsboro,  NJ  08536
Product CodeJXG  
CFR Regulation Number882.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-08-05
Decision Date2009-11-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10381780034025 K092395 000
10381780034018 K092395 000
10381780033837 K092395 000
10381780033820 K092395 000

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