Home / 510(k) Clearances / K171531

510(k) K171531

Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle by Care Fusion — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2017
Date Received
May 25, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type

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