FDA 510(k)

Tyvek Roll with CI for STERLINK Sterilizer

Número K: K223025 · 2023-05-09

Data da decisão2023-05-09

Código do produtoFRG

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Tyvek Roll with CI for STERLINK Sterilizer is the device name listed in this FDA 510(k) record. The listed applicant is Plasmapp Co,., Ltd.. It received FDA 510(k) clearance on 2023-05-09 under 510(k) number K223025. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Tyvek Roll with CI for STERLINK Sterilizer?

Tyvek Roll with CI for STERLINK Sterilizer is a medical device that received FDA 510(k) clearance on 2023-05-09. The listed applicant is Plasmapp Co,., Ltd.. The 510(k) number is K223025.

When did Tyvek Roll with CI for STERLINK Sterilizer receive FDA 510(k) clearance?

Tyvek Roll with CI for STERLINK Sterilizer received FDA 510(k) clearance on 2023-05-09, under 510(k) number K223025.

Who is the listed applicant for Tyvek Roll with CI for STERLINK Sterilizer?

The FDA 510(k) record lists Plasmapp Co,., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tyvek Roll with CI for STERLINK Sterilizer?

The FDA product code for Tyvek Roll with CI for STERLINK Sterilizer is FRG.

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Outros registros que listam Plasmapp Co,., Ltd. como candidato(a)

K231169STERLINK 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)K223015STERLINK™ FPS-15s Plus esterilizador com cassetę STERPACK™ plus K223023Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)K220345STERLINK 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)K212198Tyvek(R) Roll with CI for STERLINKTM Sterilizer K212193Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

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Fonte oficial

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