FDA 510(k) Application Details - K072185

Device Classification Name Cleaner, Air, Medical Recirculating

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510(K) Number K072185
Device Name Cleaner, Air, Medical Recirculating
Applicant AIRISTAR TECHNOLOGIES, LLC
PO BOX 7007
DEERFIELD, IL 60015 US
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Contact DANIEL KAMM
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Regulation Number 880.5045

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Classification Product Code FRF
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Date Received 08/06/2007
Decision Date 03/27/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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