Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017398283

FEI Number

3017398283

Entity Name

SEJONG HEALTHCARE CO., LTD.

City/State/Country

Paju Gyeonggi, KR

Establishment Address

1502-1 Tongil-ro, Paju-eup, Paju Gyeonggi 10836, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SEJONG HEALTHCARE CO., LTD. (Owner Number: 10075988)

Owner / Operator Contact Address

1502-1 Tongil-ro, Paju-eup, Paju, KR-41 10836, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Isolation Gown Dental Mask H Non-Surgical Gown Dental Mask W Cover Gown Dental Bibs Surgical Drapes and Accessories Equipment Covers Surgical Drape Accessories Surgical Packs Surgical Drapes Surgical Drape Sterile Wraps Back Table Covers Cover Gown Isolation Gown Non-Surgical Gown Endoscopy Gown Endoscopy Pants Patient Exam Gown Patient Exam Pants Pillow Cover Bed Sheets

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-07-02
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2022-03-20
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-07-02
FME	Gown, Examination	General Hospital	Class 1	880.6265	2021-06-18
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2021-06-18

Official Correspondent

KYU NAM HWANG

US Agent Details

DAVID BYUN Business: CGETC, INC. Email: david@cgetc.com Phone: (909) 2612252

Related Public Records

Same Entity

SEJONG HEALTHCARE 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 3017398283. Last updated year: 2026. Please use registration number 3017398283 when referencing this establishment in official correspondence.