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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 K191909
Device Name HepaShield Bacterial Viral Breathing System Filter
Applicant
Flexicare Medical Limited
Cynon Valley Business Park
Mountain Ash,  GB cf45 4er
Applicant Contact Joel Biddle
Correspondent
Flexicare Medical Limited
Cynon Valley Business Park
Mountain Ash,  GB cf45 4er
Correspondent Contact Joel Biddle
Regulation Number868.5260
Classification Product Code
CAH  
Date Received07/17/2019
Decision Date 03/23/2020
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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