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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K192375
Device Name Intellifuse Administration and Intellifuse Blood Administration Sets
Applicant
Smiths Medical Asd, Inc.
6000 Nathan Ln. N
Plymouth,  MN  55442
Applicant Contact Wendy Hills
Correspondent
Mrc/X, LLC
6075 Poplar Ave., Suite 500
Memphis,  TN  38119
Correspondent Contact Danielle Besal
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/30/2019
Decision Date 09/18/2020
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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