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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
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