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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 K172592
Device Name CADD Yellow High Volume Administration Set with NRFit connector
Applicant
Smiths Medical Asd, Inc.
6000 Nathan Ln. N
Plymouth,  MN  55442
Applicant Contact Michael R. Johnson
Correspondent
Smiths Medical Asd, Inc.
6000 Nathan Ln. N
Plymouth,  MN  55442
Correspondent Contact Sunny Teekasingh
Regulation Number880.5440
Classification Product Code
PWH  
Date Received08/29/2017
Decision Date 05/17/2018
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
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