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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 culture, intravaginal, assisted reproduction
De Novo Number DEN150008
Device Name INVOcell
Requester
invo bioscience
407 r mystic avenue
medford,  MA  02155 -6335
Contact kathleen karloff
Regulation Number884.6165
Classification Product Code
OYO  
Date Received02/23/2015
Decision Date 11/02/2015
Decision granted (DENG)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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