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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nebulizer (direct patient interface)
510(k) Number K072163
Device Name HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5
Applicant
3A HEALTH CARE S.R.L.
5 TIMBER LANE
NORTH READING,  MA  01864
Applicant Contact MAUREEN O'CONNELL
Correspondent
3A HEALTH CARE S.R.L.
5 TIMBER LANE
NORTH READING,  MA  01864
Correspondent Contact MAUREEN O'CONNELL
Regulation Number868.5630
Classification Product Code
CAF  
Date Received08/06/2007
Decision Date 03/06/2008
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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