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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 K050183
Device Name SILFAB SUPER 2 MAX COMPRESSOR, N28 SERIES
Applicant
Silvestrin Fabris S.R.L.
Av. La Plata 1560
Buenos Aires,  AR 1250
Applicant Contact FEDERICO SILVESTRIN
Correspondent
Silvestrin Fabris S.R.L.
Av. La Plata 1560
Buenos Aires,  AR 1250
Correspondent Contact FEDERICO SILVESTRIN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received01/27/2005
Decision Date 08/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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