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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 K010616
Device Name DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A
Applicant
HMI INDUSTRIES, INC.
13325 DARICE PKWY.
STRONGVILLE,  OH  44149
Applicant Contact JACQUELINE PERCELL
Correspondent
HMI INDUSTRIES, INC.
13325 DARICE PKWY.
STRONGVILLE,  OH  44149
Correspondent Contact JACQUELINE PERCELL
Regulation Number880.5045
Classification Product Code
FRF  
Date Received03/01/2001
Decision Date 03/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
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