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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 K251583
Device Name Ambu® Virobac II® Exhalation Filter
Applicant
Ambu A/S
Baltorpbakken 13
Ballerup,  DK 2750
Applicant Contact Lenka Vaculciakova
Correspondent
Ambu, Inc.
6721 Columbia Gateway Dr., Suite 200
Columbia,  MD  21046
Correspondent Contact Sanjay Parikh
Regulation Number868.5260
Classification Product Code
CAH  
Date Received05/23/2025
Decision Date 04/30/2026
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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