FDA 510(k)

Bi-Ostetic Bioactive Glass Foam

Número K: K170917 · 2017-10-30

RequerenteBerkeley Advanced Biomaterials

Data da decisão2017-10-30

Código do produtoMQV

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Bi-Ostetic Bioactive Glass Foam is the device name listed in this FDA 510(k) record. The listed applicant is Berkeley Advanced Biomaterials. It received FDA 510(k) clearance on 2017-10-30 under 510(k) number K170917. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Bi-Ostetic Bioactive Glass Foam?

Bi-Ostetic Bioactive Glass Foam is a medical device that received FDA 510(k) clearance on 2017-10-30. The listed applicant is Berkeley Advanced Biomaterials. The 510(k) number is K170917.

When did Bi-Ostetic Bioactive Glass Foam receive FDA 510(k) clearance?

Bi-Ostetic Bioactive Glass Foam received FDA 510(k) clearance on 2017-10-30, under 510(k) number K170917.

Who is the listed applicant for Bi-Ostetic Bioactive Glass Foam?

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

What is the FDA product code for Bi-Ostetic Bioactive Glass Foam?

The FDA product code for Bi-Ostetic Bioactive Glass Foam is MQV.

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Fonte oficial

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