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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 carbon dioxide gas controlled tissue expander
De Novo Number DEN150055
Device Name AeroForm Tissue Expander System
Requester
airxpanders, inc.
1047 elwell court
palo alto,  CA  94303
Contact robin` bush
Regulation Number878.3510
Classification Product Code
PQN  
Date Received12/07/2015
Decision Date 12/21/2016
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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