Data / Medical devices / South Korea / Chiyewon Co., Ltd.
Chiyewon Co., Ltd.: FDA-registered device maker in Guri-si Gyeonggi, South Korea, 1 510(k) clearance
Chiyewon Co., Ltd. is registered with the FDA (registration 3011802717) in Guri-si Gyeonggi, South Korea. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 5, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011802717
- Address
- 1F, 3F, 196, Donggureung-ro, Guri-si Gyeonggi, South Korea, 11909
- Owner or operator
- Chiyewon Co., Ltd. (10049595)
- Roles
- Manufacturer
- First device listed
- June 25, 2015
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bone Grafting Material, Animal Source | NPM | 2 | 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 |
|---|---|---|---|---|---|---|
| June 5, 2015 | K140021 | TI-OSS | NPM | Substantially Equivalent | Chiyewon | accessdata.fda.gov |
Compare with other makers
Updated June 5, 2015. 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.