Green Smart (Model: PHT-35LHS)

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 Green Smart (model: Pht-35lhs).

Pre-market Notification Details

Device IDK162660
510k NumberK162660
Device Name:Green Smart (Model: PHT-35LHS)
ClassificationX-ray, Tomography, Computed, Dental
Applicant VATECH CO., LTD 13, SAMSUNG 1-RO 2-GIL Hwaseong-si,  KR 445-170
ContactDaniel Kim
CorrespondentDave Kim
MTECH GROUP 8310 BUFFALO SPEEDWAY Houston,  TX  77025
Product CodeOAS  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-09-26
Decision Date2016-10-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800016401325 K162660 000
08800016401318 K162660 000
08800016401301 K162660 000

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