K-number	K240318
Device name	SITTER 3.5mm Versatile System
Applicant	Bonebridge AG
Product code	HRS
Device class	Class II
Decision date	Aug 23, 2024
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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SITTER 3.5mm Versatile System

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