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510(k) K012549

ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM by Healthway Products, Inc. — Product Code FRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2002
Date Received
August 7, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleaner, Air, Medical Recirculating
Device Class
Class II
Regulation Number
880.5045
Review Panel
HO
Submission Type

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