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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, tracheal (w/wo connector)
510(k) Number K091591
Device Name FLEXICARE MEDICAL ENDOTRACHEAL TUBES
Applicant
FLEXICARE MEDICAL LTD.
CYNON VALLEY BUSINESS PARK
MOUTAIN ASH
MID GLAMORGAN,  GB CF45 4ER
Applicant Contact DAVID MOYNHAM
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number868.5730
Classification Product Code
BTR  
Date Received06/02/2009
Decision Date 06/17/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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