FDA 510(k)

BioSiCar Silicone Implant

Número K: K193392 · 2020-07-20

Data da decisão2020-07-20

Código do produtoMIB

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

BioSiCar Silicone Implant is the device name listed in this FDA 510(k) record. The listed applicant is Metalware Technology Corp.. It received FDA 510(k) clearance on 2020-07-20 under 510(k) number K193392. The device is classified under product code MIB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BioSiCar Silicone Implant?

BioSiCar Silicone Implant is a medical device that received FDA 510(k) clearance on 2020-07-20. The listed applicant is Metalware Technology Corp.. The 510(k) number is K193392.

When did BioSiCar Silicone Implant receive FDA 510(k) clearance?

BioSiCar Silicone Implant received FDA 510(k) clearance on 2020-07-20, under 510(k) number K193392.

Who is the listed applicant for BioSiCar Silicone Implant?

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

What is the FDA product code for BioSiCar Silicone Implant?

The FDA product code for BioSiCar Silicone Implant is MIB.

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