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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 K984116
Device Name HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C
Applicant
Abatement Technologies, Inc.
2220 Northmont Pkwy., #100
Duluth,  GA  30096
Applicant Contact DAVID WILLYARD
Correspondent
Abatement Technologies, Inc.
2220 Northmont Pkwy., #100
Duluth,  GA  30096
Correspondent Contact DAVID WILLYARD
Regulation Number880.5045
Classification Product Code
FRF  
Date Received11/17/1998
Decision Date 06/24/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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