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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 K110273
Device Name AEROVENT PLUS CHC
Applicant
Monaghan Medical Corporation
5 Latour Ave., Suite 1600
Plattsburgh,  NY  12901
Applicant Contact CARI J REIL
Correspondent
Monaghan Medical Corporation
5 Latour Ave., Suite 1600
Plattsburgh,  NY  12901
Correspondent Contact CARI J REIL
Regulation Number868.5630
Classification Product Code
CAF  
Date Received01/31/2011
Decision Date 06/09/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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