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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 parathyroid autofluorescence detection device
De Novo Number DEN170056
Device Name Parathyroid Detection (Model PTeye) System
Requester
aibiomed, corp.
107 west gutierrez sreet
santa barbara,  CA  93101
Contact al memmolo
Regulation Number878.4550
Classification Product Code
QDF  
Date Received09/25/2017
Decision Date 11/02/2018
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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