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510(k) K192375

Intellifuse Administration and Intellifuse Blood Administration Sets by Smiths Medical Asd, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2020
Date Received
August 30, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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