Decimal Bolus

System, Planning, Radiation Therapy Treatment

.decimal, LLC

The following data is part of a premarket notification filed by .decimal, Llc with the FDA for Decimal Bolus.

Pre-market Notification Details

Device IDK211511
510k NumberK211511
Device Name:Decimal Bolus
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant .decimal, LLC 121 Central Park Place Sanford,  FL  32771
ContactKevin Erhart
CorrespondentKevin Erhart
.decimal, LLC 121 Central Park Place Sanford,  FL  32771
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-14
Decision Date2021-07-01

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