Name: Predicase
Price: 199 USD

K-number	K191457
Device name	BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)
Applicant	Med-El Elektromedizinische Geraete GmbH
Product code	PFO
Device class	Class II
Decision date	Sep 18, 2019
Decision	Substantially Equivalent
Regulation	874.3340

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Source

View the full FDA submission: accessdata.fda.gov

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BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)

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