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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
510(k) Number K960593
Device Name SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100
Applicant
Aradigm Corp.
26219 Eden Landing Rd.
Hayward,  CA  94545
Applicant Contact DIANE JACHINOWSKI
Correspondent
Aradigm Corp.
26219 Eden Landing Rd.
Hayward,  CA  94545
Correspondent Contact DIANE JACHINOWSKI
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received02/12/1996
Decision Date 05/10/1996
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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