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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 K904834
Device Name INTAVENT LARYNGEAL MASK
Applicant
INTAVENT INTL. S.A.
ST. ANDREWS, ABNEY CT DR.
BOURNE END, BUCKS SL8 5DL
ENGLAND,  GB
Applicant Contact BRAIN
Correspondent
INTAVENT INTL. S.A.
ST. ANDREWS, ABNEY CT DR.
BOURNE END, BUCKS SL8 5DL
ENGLAND,  GB
Correspondent Contact BRAIN
Regulation Number868.5110
Classification Product Code
CAE  
Date Received10/24/1990
Decision Date 07/26/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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