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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 K241339
Device Name Besmed Bacterial Filter and HMEF
Applicant
Besmed Health Business Corp
# 5, Lane 116, Wu-Kong 2nd Rd.
New Taipei City,  TW 24888
Applicant Contact Sarah Lu
Correspondent
Besmed Health Business Corp
# 5, Lane 116, Wu-Kong 2nd Rd.
New Taipei City,  TW 24888
Correspondent Contact Steven Wong
Regulation Number868.5260
Classification Product Code
CAH  
Date Received05/13/2024
Decision Date 11/14/2024
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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