FDA 510(k)

High Retention Attachment System

Número K: K213391 · 2022-01-11

Data da decisão2022-01-11

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

High Retention Attachment System is the device name listed in this FDA 510(k) record. The listed applicant is Zest Anchors, LLC. It received FDA 510(k) clearance on 2022-01-11 under 510(k) number K213391. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the High Retention Attachment System?

High Retention Attachment System is a medical device that received FDA 510(k) clearance on 2022-01-11. The listed applicant is Zest Anchors, LLC. The 510(k) number is K213391.

When did High Retention Attachment System receive FDA 510(k) clearance?

High Retention Attachment System received FDA 510(k) clearance on 2022-01-11, under 510(k) number K213391.

Who is the listed applicant for High Retention Attachment System?

The FDA 510(k) record lists Zest Anchors, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for High Retention Attachment System?

The FDA product code for High Retention Attachment System is NHA.

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Fonte oficial

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