FDA 510(k)

Exofin High Viscosity Tissue Adhesive

Número K: K152476 · 2016-02-09

RequerenteChemence Medical Products, Inc.

Data da decisão2016-02-09

Código do produtoMPN

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Exofin High Viscosity Tissue Adhesive is the device name listed in this FDA 510(k) record. The listed applicant is Chemence Medical Products, Inc.. It received FDA 510(k) clearance on 2016-02-09 under 510(k) number K152476. The device is classified under product code MPN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Exofin High Viscosity Tissue Adhesive?

Exofin High Viscosity Tissue Adhesive is a medical device that received FDA 510(k) clearance on 2016-02-09. The listed applicant is Chemence Medical Products, Inc.. The 510(k) number is K152476.

When did Exofin High Viscosity Tissue Adhesive receive FDA 510(k) clearance?

Exofin High Viscosity Tissue Adhesive received FDA 510(k) clearance on 2016-02-09, under 510(k) number K152476.

Who is the listed applicant for Exofin High Viscosity Tissue Adhesive?

The FDA 510(k) record lists Chemence Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Exofin High Viscosity Tissue Adhesive?

The FDA product code for Exofin High Viscosity Tissue Adhesive is MPN.

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