Name: Predicase
Price: 199 USD

K-number	K092395
Device name	OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM
Applicant	Integra Lifesciences Corp.
Product code	JXG
Device class	Class II
Decision date	Nov 19, 2009
Decision	Substantially Equivalent
Regulation	882.5550

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.