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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
Predetermined Change
Control Plan Authorized		 No
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