Name: Predicase
Price: 199 USD

K-number	K162309
Device name	StealthStation S8 System Platforms and StealthStation Cranial Software
Applicant	Medtronic Navigation, Inc.
Product code	HAW
Device class	Class II
Decision date	Mar 31, 2017
Decision	Substantially Equivalent
Regulation	882.4560

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Source

View the full FDA submission: accessdata.fda.gov

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StealthStation S8 System Platforms and StealthStation Cranial Software

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