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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 K132988
Device Name VITAL COUGH
Applicant
LUNG ASSIST, INC.
4655 KIRKWOOD COURT
BOULDER,  CO  80301
Applicant Contact LEWIS WARD
Correspondent
LUNG ASSIST, INC.
4655 KIRKWOOD COURT
BOULDER,  CO  80301
Correspondent Contact LEWIS WARD
Regulation Number868.5905
Classification Product Code
NHJ  
Date Received09/24/2013
Decision Date 03/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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