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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
510(k) Number K160540
Device Name FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM
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 Number868.5270
Classification Product Code
BZE  
Subsequent Product Code
BTT  
Date Received02/26/2016
Decision Date 06/23/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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