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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, positive pressure breathing, intermittent
510(k) Number K120277
Device Name VITAL COUGH
Original Applicant
LUNG ASSIST, INC.
4655 kirkwood court
boulder,  CO  80301
Original Contact lewis ward
Regulation Number868.5905
Classification Product Code
NHJ  
Date Received01/30/2012
Decision Date 09/12/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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