TAURUS C1

Unit, Operative Dental

SHINHUNG COMPANY LTD

The following data is part of a premarket notification filed by Shinhung Company Ltd with the FDA for Taurus C1.

Pre-market Notification Details

Device IDK151996
510k NumberK151996
Device Name:TAURUS C1
ClassificationUnit, Operative Dental
Applicant SHINHUNG COMPANY LTD SHINHUNG BLDG, 450 CHEONGPA-RO, JUNG-GU Seoul,  KR 100-858
ContactSky Shin
CorrespondentDave Kim
MTECH GROUP 8310 BUFFALO SPEEDWAY Houston,  TX  77025
Product CodeEIA  
CFR Regulation Number872.6640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-20
Decision Date2016-01-22
Summary:summary

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