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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 K884472
Device Name AIR-ELECTRONIC AIR CLEANER (FILTER)
Applicant
White-Rodgers, Div. Emerson Electric Co.
303 N. Industrial Park Rd.
Harrison,  AR  72601
Applicant Contact JIM L MILUM
Correspondent
White-Rodgers, Div. Emerson Electric Co.
303 N. Industrial Park Rd.
Harrison,  AR  72601
Correspondent Contact JIM L MILUM
Regulation Number880.5045
Classification Product Code
FRF  
Date Received10/25/1988
Decision Date 01/19/1989
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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