FDA 510(k)

ROCCIA® ACIF

Número K: K162587 · 2017-01-26

Data da decisão2017-01-26

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ROCCIA® ACIF 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 2017-01-26 under 510(k) number K162587. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ROCCIA® ACIF?

ROCCIA® ACIF is a medical device that received FDA 510(k) clearance on 2017-01-26. The listed applicant is Silony Medical GmbH. The 510(k) number is K162587.

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

ROCCIA® ACIF received FDA 510(k) clearance on 2017-01-26, under 510(k) number K162587.

Who is the listed applicant for ROCCIA® ACIF?

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® ACIF?

The FDA product code for ROCCIA® ACIF is ODP.

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Fonte oficial

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