K-number	K212284
Device name	Disposable Automatic Core Biopsy Instrument
Applicant	Suzhou Leapmed Healthcare Corporation
Product code	KNW
Device class	Class II
Decision date	Nov 10, 2021
Decision	Substantially Equivalent
Regulation	876.1075

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Source

View the full FDA submission: accessdata.fda.gov

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Disposable Automatic Core Biopsy Instrument

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