Name: Predicase
Price: 199 USD

K-number	K192099
Device name	MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System
Applicant	Medax Srl Unipersonale
Product code	KNW
Device class	Class II
Decision date	Apr 2, 2020
Decision	Substantially Equivalent
Regulation	876.1075

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Source

View the full FDA submission: accessdata.fda.gov

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MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System

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