Name: Predicase
Price: 199 USD

K-number	K161409
Device name	M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem
Applicant	Mermaid Medical A/S
Product code	KNW
Device class	Class II
Decision date	Aug 2, 2016
Decision	Substantially Equivalent
Regulation	876.1075

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Source

View the full FDA submission: accessdata.fda.gov

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M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem

Everything you need for a 510(k) submission. Nothing you don't.