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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 K230483
Device Name Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
Applicant
Passy-Muir, Inc.
17992 Mitchell So., Suite 200
Irvine,  CA  92614
Applicant Contact Donna Malter
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number868.5260
Classification Product Code
CAH  
Date Received02/23/2023
Decision Date 09/16/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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