Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017846547

FEI Number

3017846547

Entity Name

LTY CO., LTD.

City/State/Country

Hwaseong-si Gyeonggi, KR

Establishment Address

214-95, 214-97, 214-99, 214-101, Naehyang-ro, Jeongnam-myeon, Hwaseong-si Gyeonggi 18523, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LTY CO., LTD. (Owner Number: 10078745)

Owner / Operator Contact Address

214-95, 214-97, 214-99, 214-101, Naehyang-ro, Jeongnam-myeon, Hwaseong-si, KR-41 18523, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LTY spot patch Madeca Medi Patch Special LTY PURE MASK(KF94) LTY PURE MASK(KF80) LTY PURE MASK(KF80) LTY PURE MASK(KF94)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2021-08-12
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-11-03
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-11-03

Official Correspondent

GYEONG MO YANG

US Agent Details

Priscilla Chung Business: LK Consulting Group USA, Inc. Email: juhee.c@lkconsultinggroup.com Phone: (714) 9225276

Related Public Records

Same Entity

LTY CO., LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3042206168	LTY Jeonju Factory Co., Ltd.	Wanju-gun Jeonbuk, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Similar Registrations

Registration Number	Establishment Name	Location
3016445778	LABNPEOPLE	Yangju-si Gyeonggi, KR
3033273018	RASHENDZ, INC.	St Petersburg, FL, US
3008656870	DALIAN ORIENTECH CO.,LTD	Dalian Liaoning, CN
1629057	WINFIELD LABORATORIES, INC.	Richardson, TX, US
3021695082	BEONE CO., LTD.	Gimpo Gyeonggi, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017846547. Last updated year: 2026. Please use registration number 3017846547 when referencing this establishment in official correspondence.