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510(k) K072185

AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000 by Airistar Technologies, LLC — Product Code FRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2008
Date Received
August 6, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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