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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 endoscopic light-projecting measuring device
De Novo Number DEN210032
Device Name AccuMeasure System
Requester
RQMIS Inc.
110 haverhill road
suite 524
amesbury,  MA  01913
Contact barry sands
Regulation Number876.1530
Classification Product Code
QTH  
Date Received08/09/2021
Decision Date 07/26/2022
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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