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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Purifier, Air, Ultraviolet, Medical
510(k) Number K884579
Device Name UV AIR STERILIGHT
Applicant
Allseasons Environmental Control, Inc.
331 Exeter Rd., Units 23-25
London, Ontario,  CA
Applicant Contact DAVID RITCHIE
Correspondent
Allseasons Environmental Control, Inc.
331 Exeter Rd., Units 23-25
London, Ontario,  CA
Correspondent Contact DAVID RITCHIE
Regulation Number880.6500
Classification Product Code
FRA  
Date Received11/03/1988
Decision Date 12/12/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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