Cleared Traditional

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

K092395 · Integra Lifesciences Corp. · Neurology
Nov 2009
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K092395 is an FDA 510(k) clearance for the OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM, a Shunt, Central Nervous System And Components (Class II — Special Controls, product code JXG), submitted by Integra Lifesciences Corp. (Planisboro, US). The FDA issued a Cleared decision on November 19, 2009, 106 days after receiving the submission on August 5, 2009. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5550.

Submission Details

510(k) Number K092395 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2009
Decision Date November 19, 2009
Days to Decision 106 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code JXG — Shunt, Central Nervous System And Components
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5550

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