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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 K002692
Device Name DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A
Applicant
HMI INDUSTRIES, INC.
13325 darice pkwy.
strongville,  OH  44149
Applicant Contact jacqueline a purcell
Correspondent
HMI INDUSTRIES, INC.
13325 darice pkwy.
strongville,  OH  44149
Correspondent Contact jacqueline a purcell
Regulation Number880.5045
Classification Product Code
FRF  
Date Received08/29/2000
Decision Date 11/17/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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