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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 K940573
Device Name HEPA AIR CLEANER
Applicant
Duracraft Corp.
355 Main St.
Whitinsville,  MA  01588
Applicant Contact ARTHUR WONG
Correspondent
Duracraft Corp.
355 Main St.
Whitinsville,  MA  01588
Correspondent Contact ARTHUR WONG
Regulation Number880.5045
Classification Product Code
FRF  
Date Received02/08/1994
Decision Date 08/25/1994
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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