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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K171531
Device Name Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle
Applicant
Care Fusion
75 N Fairway Dr.
Vernon Hills,  IL  60061
Applicant Contact Tamara Brey
Correspondent
Care Fusion
75 N Fairway Dr.
Vernon Hills,  IL  60061
Correspondent Contact Tamara Brey
Regulation Number876.1075
Classification Product Code
KNW  
Date Received05/25/2017
Decision Date 09/11/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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