Haw River, NC, US · 7 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| FRC | Indicator, Biological Sterilization Process | Class II | General Hospital | 3 | 2022-04-12 |
| FRG | Wrap, Sterilization | Class II | General Hospital | 2 | 2020-11-12 |
| FLF | Sterilizer, Ethylene-Oxide Gas | Class II | General Hospital | 1 | 2020-11-12 |
| JOJ | — | — | — | 1 | 2020-11-12 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2022-04-12 | K213296 | Anprolene SteriTest RRBI | FRC | Class II | General Hospital |
| 2021-03-03 | K202879 | EOGas 4 Endo-SteriTest RRBI | FRC | Class II | General Hospital |
| 2020-11-12 | K200336 | Tyvek Sterilization Pouches with Chevron Seal | FRG | Class II | General Hospital |
| 2020-11-12 | K200335 | Sterisheet Sterilization Wrap | FRG | Class II | General Hospital |
| 2020-11-12 | K200334 | AN1036 Dosimeter | JOJ | — | — |
| 2020-11-12 | K192980 | EOGas 4 Endo-SteriTest | FRC | Class II | General Hospital |
| 2020-11-12 | K192978 | EOGas 4 Ethylene Oxide Gas Sterilizer | FLF | Class II | General Hospital |