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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Airway, Oropharyngeal, Anesthesiology
510(k) Number K130304
FOIA Releasable 510(k) K130304
Device Name LMA FAMILY OF AIRWAYS
Applicant
The Laryngeal Mask Co., Ltd.
2917 Weck Dr.
P.O. Box 12600
Research Triangle Park,  NC  27709
Applicant Contact PAUL DRYDEN
Correspondent
The Laryngeal Mask Co., Ltd.
2917 Weck Dr.
P.O. Box 12600
Research Triangle Park,  NC  27709
Correspondent Contact PAUL DRYDEN
Regulation Number868.5110
Classification Product Code
CAE  
Date Received02/07/2013
Decision Date 05/30/2014
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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