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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 K072494
Device Name AG-CLASSIC
Applicant
MEDEL S.P.A.
112 CAVISTION WAY
CARY,  NC  27519
Applicant Contact TERRANCE M O'BRIEN
Correspondent
MEDEL S.P.A.
112 CAVISTION WAY
CARY,  NC  27519
Correspondent Contact TERRANCE M O'BRIEN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/05/2007
Decision Date 02/12/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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