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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K160887
FOIA Releasable 510(k) K160887
Device Name Cook Intraosseous Infusion Needles
Applicant
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Applicant Contact JULIA FERGUSON
Correspondent
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Correspondent Contact JULIA FERGUSON
Regulation Number880.5570
Classification Product Code
FMI  
Date Received03/31/2016
Decision Date 07/26/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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