Name: Predicase
Price: 199 USD

K-number	K200504
Device name	BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote
Applicant	Med-El Elektromedizinische Geraete GmbH
Product code	PFO
Device class	Class II
Decision date	Jul 29, 2020
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, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote

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