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510(k) K223015

STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette by Plasmapp Co,., Ltd. — Product Code MLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2023
Date Received
September 29, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Chemical
Device Class
Class II
Regulation Number
880.6860
Review Panel
HO
Submission Type

Other clearances by Plasmapp Co,., Ltd.

  • K231169 — STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK (May 25, 2023)
  • K223025 — Tyvek Roll with CI for STERLINK Sterilizer (May 9, 2023)
  • K223023 — Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD (May 9, 2023)
  • K220345 — STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STE (April 14, 2023)
  • K212198 — Tyvek(R) Roll with CI for STERLINKTM Sterilizer (October 22, 2021)
  • K212193 — Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD (October 22, 2021)
  • K212200 — STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette (October 22, 2021)

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  • K220345 — STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STE (April 14, 2023)
  • K222093 — V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Ster (September 9, 2022)
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