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FDA 510(k)

Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors

Número K: K172800 · 2018-06-14

RequerenteSmiths Medical Asd, Inc.
Data da decisão2018-06-14
Código do produtoMIA
Comité consultivoAN
DecisãoSubstantially Equivalent

Resumo do dispositivo

Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2018-06-14 under 510(k) number K172800. The device is classified under product code MIA. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors?

Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors is a medical device that received FDA 510(k) clearance on 2018-06-14. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K172800.

When did Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors receive FDA 510(k) clearance?

Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors received FDA 510(k) clearance on 2018-06-14, under 510(k) number K172800.

Who is the listed applicant for Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors?

The FDA 510(k) record lists Smiths Medical Asd, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors?

The FDA product code for Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors is MIA.

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Fonte oficial

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