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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 K051993
Device Name LMA FASTRACH ETT SINGLE USE
Applicant
THE LARYNGEAL MASK CO.,LTD.
9360 TOWNE CENTRE DR.
SAN DIEGO,  CA  92121
Applicant Contact FOSTER BOOP
Correspondent
THE LARYNGEAL MASK CO.,LTD.
9360 TOWNE CENTRE DR.
SAN DIEGO,  CA  92121
Correspondent Contact FOSTER BOOP
Regulation Number868.5730
Classification Product Code
BTR  
Date Received07/25/2005
Decision Date 12/13/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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