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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name intravascular administration set, automated air removal system
De Novo Number DEN080009
510(K) Number K080644
Device Name AIRPURGE
Requester
anesthesia safety products, llc
155-m new boston street
suite 127
woburn,  MA  01801
Contact ihsan a haddad
Regulation Number880.5445
Classification Product Code
OKL  
Date Received10/29/2008
Decision Date 03/04/2014
Decision granted (DENG)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
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