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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 K942434
Device Name BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER
Applicant
Bionaire Corp.
2000-32nd Ave.
Lachine, Quebec,  CA H8T 3H7
Applicant Contact PAUL CROWHURST
Correspondent
Bionaire Corp.
2000-32nd Ave.
Lachine, Quebec,  CA H8T 3H7
Correspondent Contact PAUL CROWHURST
Regulation Number880.5045
Classification Product Code
FRF  
Date Received05/20/1994
Decision Date 12/14/1994
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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