K-number	K212822
Device name	Disposable Coaxial Biopsy Needle
Applicant	Suzhou Leapmed Healthcare Corporation
Product code	FCG
Device class	Class II
Decision date	Jul 6, 2022
Decision	Substantially Equivalent
Regulation	876.1075

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Source

View the full FDA submission: accessdata.fda.gov

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Disposable Coaxial Biopsy Needle

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