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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 K032972
Device Name AEROCHAMBER MAX VALVED HOLDING CHAMBER
Applicant
TRUDELL MEDICAL INTL.
725 THIRD ST.
LONDON, ONTARIO,  CA N5V 5G4
Applicant Contact TOM HOLBROOK
Correspondent
TRUDELL MEDICAL INTL.
725 THIRD ST.
LONDON, ONTARIO,  CA N5V 5G4
Correspondent Contact TOM HOLBROOK
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/24/2003
Decision Date 01/14/2004
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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