OSV II LOW FLOW LOW PRO VALVE

Shunt, Central Nervous System And Components

INTEGRA LIFESCIENCES CORPORATION

The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Osv Ii Low Flow Low Pro Valve.

Pre-market Notification Details

Device IDK093968
510k NumberK093968
Device Name:OSV II LOW FLOW LOW PRO VALVE
ClassificationShunt, Central Nervous System And Components
Applicant INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro,  NJ  08536
ContactDonna Millisky
CorrespondentDonna Millisky
INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro,  NJ  08536
Product CodeJXG  
CFR Regulation Number882.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-23
Decision Date2010-01-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M2729OS512P1 K093968 000
M2729OS502P1 K093968 000
M272909512P1 K093968 000
M272909500P1 K093968 000

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