Name: Predicase
Price: 199 USD

K-number	K153041
Device name	Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling
Applicant	Integra LifeSciences Corporation
Product code	JXG
Device class	Class II
Decision date	Mar 14, 2016
Decision	Substantially Equivalent
Regulation	882.5550

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Source

View the full FDA submission: accessdata.fda.gov

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Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling

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