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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holding Chambers, Direct Patient Interface
510(k) Number K052332
Device Name AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER
Applicant
Trudell Medical Intl.
725 Third St.
London,  CA N5V 5G4
Applicant Contact JOHN STRAATMAN
Correspondent
Trudell Medical Intl.
725 Third St.
London,  CA N5V 5G4
Correspondent Contact JOHN STRAATMAN
Regulation Number868.5630
Classification Product Code
NVP  
Date Received08/26/2005
Decision Date 09/21/2005
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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