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510(k) K081062

AIRSONNETT AIRSHOWER AIR 3 by Airsonett, Inc. — Product Code FRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2008
Date Received
April 14, 2008
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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