Name: Predicase
Price: 199 USD

K-number	K230015
Device name	OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver
Applicant	Laurane Medical Sas
Product code	KNW
Device class	Class II
Decision date	Jun 16, 2023
Decision	Substantially Equivalent
Regulation	876.1075

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Source

View the full FDA submission: accessdata.fda.gov

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OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver

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

OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver