FDA 510(k)

scaffolene CL100 Bioresorbable Collagen Matrix

Número K: K192346 · 2020-02-28

RequerenteFreudenberg Technology Innovation SE & Co. KG

Data da decisão2020-02-28

Código do produtoKGN

DecisãoSubstantially Equivalent

Resumo do dispositivo

scaffolene CL100 Bioresorbable Collagen Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Freudenberg Technology Innovation SE & Co. KG. It received FDA 510(k) clearance on 2020-02-28 under 510(k) number K192346. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the scaffolene CL100 Bioresorbable Collagen Matrix?

scaffolene CL100 Bioresorbable Collagen Matrix is a medical device that received FDA 510(k) clearance on 2020-02-28. The listed applicant is Freudenberg Technology Innovation SE & Co. KG. The 510(k) number is K192346.

When did scaffolene CL100 Bioresorbable Collagen Matrix receive FDA 510(k) clearance?

scaffolene CL100 Bioresorbable Collagen Matrix received FDA 510(k) clearance on 2020-02-28, under 510(k) number K192346.

Who is the listed applicant for scaffolene CL100 Bioresorbable Collagen Matrix?

The FDA 510(k) record lists Freudenberg Technology Innovation SE & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for scaffolene CL100 Bioresorbable Collagen Matrix?

The FDA product code for scaffolene CL100 Bioresorbable Collagen Matrix is KGN.

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