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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 K163300
Device Name ThermoShield HME Filter
Applicant
Flexicare Medical Limited.
Cynon Valley Business Park
Mountain Ash,  GB CF45 4ER
Applicant Contact Joel Biddle
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number868.5260
Classification Product Code
CAH  
Date Received11/22/2016
Decision Date 03/22/2017
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
Predetermined Change
Control Plan Authorized		 No
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