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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 K930521
Device Name AIR CLEANERS WITH HEPA FILTRATION
Applicant
THE RIVAL CO.
1001 GOLDEN DR.
CLINTON,  MO  64735
Applicant Contact JAMES FERGUSON
Correspondent
THE RIVAL CO.
1001 GOLDEN DR.
CLINTON,  MO  64735
Correspondent Contact JAMES FERGUSON
Regulation Number880.5045
Classification Product Code
FRF  
Date Received02/02/1993
Decision Date 06/16/1995
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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