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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
Predetermined Change
Control Plan Authorized		 No
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