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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 K063103
Device Name AG-EDGE, MODEL 91200
Applicant
MEDEL S.P.A.
112 CAVISTON WAY
CARY,  NC  27519
Applicant Contact TERRENCE O'BRIEN
Correspondent
MEDEL S.P.A.
112 CAVISTON WAY
CARY,  NC  27519
Correspondent Contact TERRENCE O'BRIEN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received10/10/2006
Decision Date 01/08/2007
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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