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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 K062484
Device Name FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS
Applicant
FLAEM NUOVA S.P.A.
5 TIMBER LANE
north reading,  MA  01864
Applicant Contact maureen o'connell
Correspondent
FLAEM NUOVA S.P.A.
5 TIMBER LANE
north reading,  MA  01864
Correspondent Contact maureen o'connell
Regulation Number868.5630
Classification Product Code
CAF  
Date Received08/25/2006
Decision Date 06/08/2007
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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