Sooil Development Co., Ltd.
Yongin-si Gyeonggi, KR
SOOIL DEVELOPMENT CO., LTD. appears in FDA device records in Yongin-si Gyeonggi, KR. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Sooil Development Co., Ltd. between 2000 and 2007. The busiest year on record is 2007, with 2. The most recent is 2007, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2002 | 1 |
| 2007 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K071418 | DANA 3CC SYRINGE INSULIN RESERVOIR | MRZ | Substantially Equivalent | |
| K063126 | DANA DIABECARE IIS | LZG | Substantially Equivalent | |
| K022317 | DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS | LZG | Substantially Equivalent | |
| K001604 | DANA DIABECARE | LZG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9616814 | 3003024060 | SOOIL DEVELOPMENT CO., LTD. | 62, Yonggu-daero 2325beon-gil, Giheung-gu, Yongin-si Gyeonggi 16922 KR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain