Data / Medical devices / South Korea / Soyagreentec Co.,ltd
Soyagreentec Co.,ltd: FDA-registered device maker in Hwaseong-si Gyeonggi, South Korea, 1 510(k) clearance
Soyagreentec Co.,ltd is registered with the FDA (registration 3004525100) in Hwaseong-si Gyeonggi, South Korea. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 24, 2007. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004525100
- Address
- 34-26, Jeyakgongdan 2-gil Hyangnam-eup, Hwaseong-si Gyeonggi, South Korea, 18622
- Owner or operator
- SOYAGREENTEC CO.,LTD (9062715)
- Roles
- Contract sterilizer, Manufacturer
- First device listed
- July 21, 2008
- Registered through
- 2026
- Brand names listed
- NANOLET, OSTEON
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bone Grafting Material, Synthetic | LYC | 2 | Contract sterilizer, Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Contract sterilizer | 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 |
|---|---|---|---|---|---|---|
| April 24, 2007 | K062834 | OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050 | LYC | Substantially Equivalent | Genoss Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Bone Grafting Material, Synthetic
- All makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Updated April 24, 2007. 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.