Park's Pectus System

Plate, Fixation, Bone

TDM Co. Ltd.

The following data is part of a premarket notification filed by Tdm Co. Ltd. with the FDA for Park's Pectus System.

Pre-market Notification Details

Device IDK191057
510k NumberK191057
Device Name:Park's Pectus System
ClassificationPlate, Fixation, Bone
Applicant TDM Co. Ltd. 69, Cheomdan Venture So-ro, 37 Beon-gil, Buk-gu Gwangju,  KR 61003
ContactJung-wook Choi
CorrespondentDave Kim
Dave Kim 1830 Buffalo Speedway Houston,  TX  77025
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-22
Decision Date2020-03-19

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