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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 K012939
Device Name AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER
Applicant
Monaghan Medical Corp.
5 Latour Ave., Suite 1600
P.O. Box 2805
Plattsburgh,  NY  12901
Applicant Contact JAMES A COCHIE
Correspondent
Monaghan Medical Corp.
5 Latour Ave., Suite 1600
P.O. Box 2805
Plattsburgh,  NY  12901
Correspondent Contact JAMES A COCHIE
Regulation Number868.5630
Classification Product Code
CAF  
Date Received08/31/2001
Decision Date 09/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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