FDA 510(k)

Tyvek(R) Roll with CI for STERLINKTM Sterilizer

N.º K: K212198 · 2021-10-22

Fecha de decisión2021-10-22

Código de productoFRG

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Tyvek(R) Roll with CI for STERLINKTM 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 2021-10-22 under 510(k) number K212198. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Tyvek(R) Roll with CI for STERLINKTM Sterilizer?

Tyvek(R) Roll with CI for STERLINKTM Sterilizer is a medical device that received FDA 510(k) clearance on 2021-10-22. The listed applicant is Plasmapp Co,., Ltd.. The 510(k) number is K212198.

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

Tyvek(R) Roll with CI for STERLINKTM Sterilizer received FDA 510(k) clearance on 2021-10-22, under 510(k) number K212198.

Who is the listed applicant for Tyvek(R) Roll with CI for STERLINKTM 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(R) Roll with CI for STERLINKTM Sterilizer?

The FDA product code for Tyvek(R) Roll with CI for STERLINKTM Sterilizer is FRG.

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Otros registros que enlistan a Plasmapp Co,., Ltd. como solicitante

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)K223025Tyvek Roll with CI for STERLINK Sterilizer K223015Estérilizador STERLINK™ FPS-15s Plus con cassetta 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)K212200STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette

Ver todos los 8 dispositivos →

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Fuente oficial

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