FDA 510(k)

Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)

Número K: K171161 · 2017-09-25

Data da decisão2017-09-25

Código do produtoMQV

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) is the device name listed in this FDA 510(k) record. The listed applicant is Dimensional Bioceramics, LLC. It received FDA 510(k) clearance on 2017-09-25 under 510(k) number K171161. 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 Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)?

Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) is a medical device that received FDA 510(k) clearance on 2017-09-25. The listed applicant is Dimensional Bioceramics, LLC. The 510(k) number is K171161.

When did Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) receive FDA 510(k) clearance?

Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) received FDA 510(k) clearance on 2017-09-25, under 510(k) number K171161.

Who is the listed applicant for Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)?

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

What is the FDA product code for Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)?

The FDA product code for Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) is MQV.

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Fonte oficial

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