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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleaner, Air, Medical Recirculating
510(k) Number K023693
Device Name MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100
Applicant
Airex, Inc.
13704 SE 17th St.
Bellevue,  WA  98005
Applicant Contact WILLIAM HASLEBACHER
Correspondent
Airex, Inc.
13704 SE 17th St.
Bellevue,  WA  98005
Correspondent Contact WILLIAM HASLEBACHER
Regulation Number880.5045
Classification Product Code
FRF  
Date Received11/01/2002
Decision Date 03/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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