K-number	K210839
Device name	SoundBite Crossing System - Peripheral (14P)
Applicant	Soundbite Medical Solutions, Inc.
Product code	PDU
Device class	Class II
Decision date	Apr 20, 2021
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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SoundBite Crossing System - Peripheral (14P)

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