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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 radiation therapy marking device
De Novo Number DEN200041
Device Name Comfort Marker 2.0.
Requester
Medical Precision B.V.
telfordstraat 9 - 30
zwolle,  NL 8013 rl
Contact roland kortenhorst
Regulation Number892.5785
Classification Product Code
QRN  
Date Received06/22/2020
Decision Date 12/10/2021
Decision granted (DENG)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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