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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Humidifier, Respiratory Gas, (Direct Patient Interface)
510(k) Number K161314
Device Name FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE
Applicant
FLEXICARE MEDICAL LIMITED
CYNON VALLEY BUSINESS PARK
MOUNTAIN ASH,  GB CF45 4ER
Applicant Contact JOEL BIDDLE
Correspondent
THIRD PARTY REVIEW GROUP, LLC
25 Independence Blvd
Warren,  NJ  07059
Correspondent Contact DAVE YUNGVIRT
Regulation Number868.5450
Classification Product Code
BTT  
Date Received05/11/2016
Decision Date 07/06/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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