Chrysalis Intelligence · Sponsors · Plasmapp Co,., Ltd.

Plasmapp Co,., Ltd.

Daejeon, KR · 8 510(k) clearances

Total clearances
8
2021-10-22 → 2023-05-25
Last 12 months
0
Product codes
3
Most recent
2023-05-25
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MLR Sterilizer, Chemical Class II General Hospital 4 2023-05-25
FRC Indicator, Biological Sterilization Process Class II General Hospital 2 2023-05-09
FRG Wrap, Sterilization Class II General Hospital 2 2023-05-09
Filings

All 510(k) clearances (8)

Date K-number Device Code Class Specialty
2023-05-25 K231169 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) MLR Class II General Hospital
2023-05-09 K223025 Tyvek Roll with CI for STERLINK Sterilizer FRG Class II General Hospital
2023-05-09 K223023 Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) FRC Class II General Hospital
2023-05-09 K223015 STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette MLR Class II General Hospital
2023-04-14 K220345 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), Terragene Chemdye (CD42), Terragene Cintape (CT40) MLR Class II General Hospital
2021-10-22 K212200 STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette MLR Class II General Hospital
2021-10-22 K212198 Tyvek(R) Roll with CI for STERLINKTM Sterilizer FRG Class II General Hospital
2021-10-22 K212193 Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) FRC Class II General Hospital