K-number	K221085
Device name	LiNA OperaScope Needle
Applicant	Lina Medical Aps
Product code	FBK
Device class	Class II
Decision date	Sep 2, 2022
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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LiNA OperaScope Needle

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