FDA 510(k)

Blustone Synergy Silica System

Número K: K172330 · 2017-12-21

Data da decisão2017-12-21

Código do produtoMQP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Blustone Synergy Silica System is the device name listed in this FDA 510(k) record. The listed applicant is Blustone Synergy. It received FDA 510(k) clearance on 2017-12-21 under 510(k) number K172330. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Blustone Synergy Silica System?

Blustone Synergy Silica System is a medical device that received FDA 510(k) clearance on 2017-12-21. The listed applicant is Blustone Synergy. The 510(k) number is K172330.

When did Blustone Synergy Silica System receive FDA 510(k) clearance?

Blustone Synergy Silica System received FDA 510(k) clearance on 2017-12-21, under 510(k) number K172330.

Who is the listed applicant for Blustone Synergy Silica System?

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

What is the FDA product code for Blustone Synergy Silica System?

The FDA product code for Blustone Synergy Silica System is MQP.

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