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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 K072019
Device Name AKITA2 APIXNEB
Applicant
ACTIVAERO AMERICA, INC.
3460 POINTE CREEK
SUITE 102
BONITA SPRINGS,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
ACTIVAERO AMERICA, INC.
3460 POINTE CREEK
SUITE 102
BONITA SPRINGS,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received07/23/2007
Decision Date 11/05/2007
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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