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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mask, oxygen, low concentration, venturi
510(k) Number K832725
Device Name DUAL DIAL VENTURI STYLE MASK
Applicant
AIRLIFE, INC.
803 N. Front St. Suite 3
mchenry,  IL  60050
Correspondent
AIRLIFE, INC.
803 N. Front St. Suite 3
mchenry,  IL  60050
Regulation Number868.5600
Classification Product Code
BYF  
Date Received08/12/1983
Decision Date 09/20/1983
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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