K-number	K100360
Device name	BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT
Applicant	Cochlear Americas
Product code	LXB
Device class	Class II
Decision date	Jul 13, 2010
Decision	Substantially Equivalent
Regulation	874.3302

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Source

View the full FDA submission: accessdata.fda.gov

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BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT

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