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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K951944
Device Name NASALFLAIR
Applicant
AIRWAYS LTD., INC.
144 LOWER MAIN ST.
MATAWAN,  NJ  07747
Applicant Contact WAYNE W DISANZA
Correspondent
AIRWAYS LTD., INC.
144 LOWER MAIN ST.
MATAWAN,  NJ  07747
Correspondent Contact WAYNE W DISANZA
Regulation Number868.5905
Classification Product Code
BZD  
Date Received04/26/1995
Decision Date 03/28/1997
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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