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510(k) K070722

PLASMAIR, MODEL T2006 by Airinspace B.V. — Product Code FRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2007
Date Received
March 15, 2007
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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