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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 K012549
Device Name ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM
Applicant
Healthway Products, Inc.
P.O. Box 2729
Syracuse,  NY  13220
Applicant Contact DICK BRIGGS
Correspondent
Healthway Products, Inc.
P.O. Box 2729
Syracuse,  NY  13220
Correspondent Contact DICK BRIGGS
Regulation Number880.5045
Classification Product Code
FRF  
Date Received08/07/2001
Decision Date 02/04/2002
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
Recalls CDRH Recalls
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