EZDENTI-I; E2; PRORA VIEW

System, Image Processing, Radiological

EWOO SOFT CO., LTD

The following data is part of a premarket notification filed by Ewoo Soft Co., Ltd with the FDA for Ezdenti-i; E2; Prora View.

Pre-market Notification Details

Device IDK131594
510k NumberK131594
Device Name:EZDENTI-I; E2; PRORA VIEW
ClassificationSystem, Image Processing, Radiological
Applicant EWOO SOFT CO., LTD 12946 KIMBERLEY LN Houston,  TX  77079
ContactDave Kim
CorrespondentDave Kim
EWOO SOFT CO., LTD 12946 KIMBERLEY LN Houston,  TX  77079
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-03
Decision Date2013-08-29
Summary:summary

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