Name: Predicase
Price: 199 USD

K-number	K161992
Device name	Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems
Applicant	Integra LifeSciences Corporation
Product code	JXG
Device class	Class II
Decision date	Sep 22, 2016
Decision	Substantially Equivalent
Regulation	882.5550

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Source

View the full FDA submission: accessdata.fda.gov

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Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems

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