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510(k) K193190

BD PureHub Disinfecting Cap by Becton, Dickinson and Company — Product Code QBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2020
Date Received
November 19, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cap, Device Disinfectant
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Disinfect needleless access valves and may act as a physical barrier to contamination if not removed for a set period of time

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