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FDA 510(k) Applications for Medical Device Product Code "GKT"
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| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K200530 | Fresenius Kabi AG | AMICUS Separator System | 09/11/2020 |
| K162462 | FRESENIUS KABI USA LLC | AMICUS Separator System, AMICUS Separator System; Refurbished | 11/23/2016 |