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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Bacterial, Breathing-Circuit
510(k) Number K211286
Device Name Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger
Applicant
Pall Corporation
25 Harbor Park Dr.
Port Washington,  NY  11050
Applicant Contact Brian Goetz
Correspondent
Hogan Lovells US LLP
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact Randy Prebula
Regulation Number868.5260
Classification Product Code
CAH  
Date Received04/27/2021
Decision Date 11/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
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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