Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle

Instrument, Biopsy

CareFusion

The following data is part of a premarket notification filed by Carefusion with the FDA for Jamshidi Bone Marrow Biopsy/aspiration Needle, Jamshidi T-handle Bone Marrow Biopsy/aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/aspiration Needle.

Pre-market Notification Details

Device IDK171531
510k NumberK171531
Device Name:Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle
ClassificationInstrument, Biopsy
Applicant CareFusion 75 North Fairway Drive Vernon Hills,  IL  60061
ContactTamara Brey
CorrespondentTamara Brey
CareFusion 75 North Fairway Drive Vernon Hills,  IL  60061
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-05-25
Decision Date2017-09-11
Summary:summary

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