Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007417776

FEI Number

3007417776

Entity Name

T&L CO., LTD. ANSEONG FACTORY

City/State/Country

ANSEONG-CITY Gyeonggi, KR

Establishment Address

70-17, WONAM-RO, WONGOK-MYEON, ANSEONG-CITY Gyeonggi 17554, KR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

T&L CO., LTD. (Owner Number: 9063857)

Owner / Operator Contact Address

27,Hyeongjero45Beon-gil,Namsa-myeon, Cheoin-gu-GU, Yongin-si, KR-41 17554, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

RenoCare Fiber Dressing RenoCare Alginate Dressing RenoPad Premium RenoFoam SB CovaWoundTM Foam Non-Adherent Foam Dressing with Adhesive Border RenoPad RenoFoam Cura C CovaWoundTM Foam Non-Adherent Foam Dressing RenoFoam FA RenoFoam A Algipack RenoFoam F RenoFoam S RenoSiGel RenoSiGel S RenoSil SUN RenoSil RenoSiGel N Reno PJ Burn Cool Sheet Burn Cool Spray RenoGel N RenoGel H RenoGel F RenoLiquid

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2009-12-28
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2009-12-28
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2018-12-23
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2009-12-28
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2018-12-23

Official Correspondent

Hyun-Ju Im

US Agent Details

Paul Lee Business: MEDIRECH GROUP LLC Email: paul.lee@meditechgrpllc.com Phone: (201) 4634171

Related Public Records

Same Entity

T&L 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 3007417776. Last updated year: 2026. Please use registration number 3007417776 when referencing this establishment in official correspondence.