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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Administrations Sets With Neuraxial Connectors
510(k) Number K162219
Device Name CADD® Infusion Disposables Portfolio with NRFit™ connectors
Applicant
Smiths Medical Asd, Inc.
6000 Nathan Lane N
Plymouth,  MN  55442
Applicant Contact Wendy J. Kivens
Correspondent
Smiths Medical Asd, Inc.
6000 Nathan Lane N
Plymouth,  MN  55442
Correspondent Contact Michael Johnson
Regulation Number880.5440
Classification Product Code
PWH  
Subsequent Product Code
LHI  
Date Received08/08/2016
Decision Date 07/20/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
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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