K-number	DEN170009
Device name	Bonebridge
Applicant	Med-El Elektromedizinische Geraete GmbH
Product code	PFO
Device class	Class II
Decision date	Jul 20, 2018
Decision	Not Substantially Equivalent
Regulation	874.3340

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View the full FDA submission: accessdata.fda.gov

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Bonebridge

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