Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015812758

FEI Number

3015812758

Entity Name

HYUNDAE MEDITECH CO., LTD.

City/State/Country

Wonju Gangwon, KR

Establishment Address

80, Cheongjeong-ro, Jijeong-myeon, Wonju Gangwon 26347, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hyundae Meditech Co., Ltd. (Owner Number: 10080349)

Owner / Operator Contact Address

80, Cheongjeong-ro, Jijeong-myeon, Wonju, KR-42 26347, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242571

PMA Number

N/A

All Registered Proprietary Names

i-Thread

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2025-06-16

Official Correspondent

Young Ho Song

US Agent Details

Daniel Hwang Email: Regulatoryaffairs@jnmglobal.net Phone: (302) 2018886

Related Public Records

Same Entity

Hyundae Meditech Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015812758. Last updated year: 2026. Please use registration number 3015812758 when referencing this establishment in official correspondence.