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510(k) K192382

CapKlenZ by Star Mountain Medical, Inc. — Product Code QBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2020
Date Received
August 30, 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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