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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 pressure wedge, perianal, for reduction of cesarean delivery
De Novo Number DEN160005
Device Name Hem-Avert Perianal Stabilizer
Requester
stetrix, inc.
70 clay st
oakland,  TN  38060
Contact mark buchanan
Regulation Number884.5210
Classification Product Code
PNU  
Date Received01/28/2016
Decision Date 12/19/2016
Decision granted (DENG)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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