K-number	K171309
Device name	BR-FHUS Navigation 1.0
Applicant	Taihao Medical, Inc.
Product code	IYO
Device class	Class II
Decision date	Sep 29, 2017
Decision	Substantially Equivalent
Regulation	892.1560

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View the full FDA submission: accessdata.fda.gov

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BR-FHUS Navigation 1.0

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