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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 K930420
Device Name HUNTER AIR CLEANERS MODEL NOS. 30100/30250/30300
Applicant
Hunter Fan Co.
2500 Frisco Ave.
Memphis,  TN  38114
Applicant Contact WALTER E CLARK
Correspondent
Hunter Fan Co.
2500 Frisco Ave.
Memphis,  TN  38114
Correspondent Contact WALTER E CLARK
Regulation Number880.5045
Classification Product Code
FRF  
Subsequent Product Code
FZH  
Date Received01/26/1993
Decision Date 09/23/1993
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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