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510(k) K211286

Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger by Pall Corporation — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2021
Date Received
April 27, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
Submission Type

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