PAX-UNI3D, PHT-7500

X-ray, Tomography, Computed, Dental

VATECH CO., LTD.

The following data is part of a premarket notification filed by Vatech Co., Ltd. with the FDA for Pax-uni3d, Pht-7500.

Pre-market Notification Details

Device IDK121400
510k NumberK121400
Device Name:PAX-UNI3D, PHT-7500
ClassificationX-ray, Tomography, Computed, Dental
Applicant VATECH CO., LTD. 12946 KIMBERLEY LN Houston,  TX  77079
ContactDave Kim
CorrespondentDave Kim
VATECH CO., LTD. 12946 KIMBERLEY LN Houston,  TX  77079
Product CodeOAS  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-10
Decision Date2012-08-28
Summary:summary

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