Data / Medical devices / South Korea / Sejong Healthcare Co., Ltd.
Sejong Healthcare Co., Ltd.: FDA-registered device maker in Paju Gyeonggi, South Korea, 1 510(k) clearance
Sejong Healthcare Co., Ltd. is registered with the FDA (registration 3017398283) in Paju Gyeonggi, South Korea. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 10, 2023. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3017398283
- Address
- 1502-1 Tongil-ro, Paju-eup, Paju Gyeonggi, South Korea, 10836
- Owner or operator
- SEJONG HEALTHCARE CO., LTD. (10075988)
- Roles
- Manufacturer
- First device listed
- July 2, 2020
- Registered through
- 2026
- Brand names listed
- Back Table Covers, Bed Sheets, Cover Gown, Dental Bibs, Dental Mask H, Dental Mask W, Endoscopy Gown, Endoscopy Pants and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Manufacturer | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Manufacturer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 10, 2023 | K220435 | SEJONG Surgical Gown Soft | FYA | Substantially Equivalent | Sejong Healthcare Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Non-Surgical Gown
- All makers of Gown, Examination
- All makers of Accessory, Surgical Apparel
- All makers of Drape, Surgical, Exempt
- All makers of Gown, Surgical
- All makers of Bedding, Disposable, Medical
Updated February 10, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.