FDA 510(k)

Pacote e Stent Nasal Sinus Novapak

Número K: K202623 · 2020-12-08

Data da decisão2020-12-08

Código do produtoLYA

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Novapak Nasal Sinus Packing and Stent is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Xomed. It received FDA 510(k) clearance on 2020-12-08 under 510(k) number K202623. The device is classified under product code LYA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Novapak Nasal Sinus Packing and Stent?

Novapak Nasal Sinus Packing and Stent is a medical device that received FDA 510(k) clearance on 2020-12-08. The listed applicant is Medtronic Xomed. The 510(k) number is K202623.

When did Novapak Nasal Sinus Packing and Stent receive FDA 510(k) clearance?

Novapak Nasal Sinus Packing and Stent received FDA 510(k) clearance on 2020-12-08, under 510(k) number K202623.

Who is the listed applicant for Novapak Nasal Sinus Packing and Stent?

The FDA 510(k) record lists Medtronic Xomed as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Novapak Nasal Sinus Packing and Stent?

The FDA product code for Novapak Nasal Sinus Packing and Stent is LYA.

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Fonte oficial

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