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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 K082878
Device Name NEVONI CLASSIC, MODEL 6600-PO
Applicant
NSR COMERCIO E REPRESENTACOES LTDA
11 PERRY DRIVE UNIT G
FOXBORO,  MA  02035
Applicant Contact POLLY SCHERMAN
Correspondent
NSR COMERCIO E REPRESENTACOES LTDA
11 PERRY DRIVE UNIT G
FOXBORO,  MA  02035
Correspondent Contact POLLY SCHERMAN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/29/2008
Decision Date 12/30/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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