FDA 510(k)

WoundClot9

Número K: K160679 · 2016-08-08

RequerenteCore Scientific Creation , Ltd.

Data da decisão2016-08-08

Código do produtoQSY

DecisãoSubstantially Equivalent

Resumo do dispositivo

WoundClot9 is the device name listed in this FDA 510(k) record. The listed applicant is Core Scientific Creation , Ltd.. It received FDA 510(k) clearance on 2016-08-08 under 510(k) number K160679. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the WoundClot9?

WoundClot9 is a medical device that received FDA 510(k) clearance on 2016-08-08. The listed applicant is Core Scientific Creation , Ltd.. The 510(k) number is K160679.

When did WoundClot9 receive FDA 510(k) clearance?

WoundClot9 received FDA 510(k) clearance on 2016-08-08, under 510(k) number K160679.

Who is the listed applicant for WoundClot9?

The FDA 510(k) record lists Core Scientific Creation , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WoundClot9?

The FDA product code for WoundClot9 is QSY.

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