FDA 510(k) Applications Submitted by Plasmapp Co., Ltd.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K223015 |
09/29/2022 |
STERLINKÖ FPS-15s Plus sterilizer with STERPACKÖ plus cassette |
Plasmapp Co., Ltd. |
| K223025 |
09/29/2022 |
Tyvek Roll with CI for STERLINK Sterilizer |
Plasmapp Co., Ltd. |
| K231169 |
04/25/2023 |
STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) |
Plasmapp Co., Ltd. |
| K220345 |
02/07/2022 |
STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terrage |
Plasmapp Co., Ltd. |
| K212193 |
07/14/2021 |
Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) |
Plasmapp Co., Ltd. |
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