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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 K092218
Device Name FLEXICARE BREATHING FILTERS
Applicant
Flexicare Medical, Ltd.
Cynon Valley Business Park
Mountain Ash
Mid Glam,  GB CF454ER
Applicant Contact DAVID MOYNHAM
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 Received07/22/2009
Decision Date 10/06/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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