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FDA 510(k)

Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”

Número K: K161067 · 2016-09-15

RequerenteEngineered Tissue Solutions, LLC
Data da decisão2016-09-15
Código do produtoQSZ
DecisãoSubstantially Equivalent

Resumo do dispositivo

Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” is the device name listed in this FDA 510(k) record. The listed applicant is Engineered Tissue Solutions, LLC. It received FDA 510(k) clearance on 2016-09-15 under 510(k) number K161067. The device is classified under product code QSZ. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”?

Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” is a medical device that received FDA 510(k) clearance on 2016-09-15. The listed applicant is Engineered Tissue Solutions, LLC. The 510(k) number is K161067.

When did Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” receive FDA 510(k) clearance?

Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” received FDA 510(k) clearance on 2016-09-15, under 510(k) number K161067.

Who is the listed applicant for Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”?

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

What is the FDA product code for Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”?

The FDA product code for Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” is QSZ.

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Fonte oficial

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