FDA 510(k)

ROCCIA® MultiLIF

Número K: K171434 · 2017-12-21

Data da decisão2017-12-21

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ROCCIA® MultiLIF is the device name listed in this FDA 510(k) record. The listed applicant is Silony Medical GmbH. It received FDA 510(k) clearance on 2017-12-21 under 510(k) number K171434. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ROCCIA® MultiLIF?

ROCCIA® MultiLIF is a medical device that received FDA 510(k) clearance on 2017-12-21. The listed applicant is Silony Medical GmbH. The 510(k) number is K171434.

When did ROCCIA® MultiLIF receive FDA 510(k) clearance?

ROCCIA® MultiLIF received FDA 510(k) clearance on 2017-12-21, under 510(k) number K171434.

Who is the listed applicant for ROCCIA® MultiLIF?

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

What is the FDA product code for ROCCIA® MultiLIF?

The FDA product code for ROCCIA® MultiLIF is MAX.

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Fonte oficial

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