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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, continuous, facility use
510(k) Number K032922
Device Name CLARISSA INFANT NCPAP CANNULA
Applicant
AIRWAYS LTD., INC.
P.O.BOX 558
CEDAR KNOLLS,  NJ  07927
Applicant Contact RICHARD J LARKIN
Correspondent
AIRWAYS LTD., INC.
P.O.BOX 558
CEDAR KNOLLS,  NJ  07927
Correspondent Contact RICHARD J LARKIN
Regulation Number868.5895
Classification Product Code
CBK  
Date Received09/22/2003
Decision Date 09/22/2004
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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