FDA 510(k)

DSM Biomedical Porcine Pericardium Dental Membrane

Número K: K160474 · 2016-06-07

RequerenteKensey Nash Corporation Dba Dsm Biomedical

Data da decisão2016-06-07

Código do produtoNPL

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

DSM Biomedical Porcine Pericardium Dental Membrane is the device name listed in this FDA 510(k) record. The listed applicant is Kensey Nash Corporation Dba Dsm Biomedical. It received FDA 510(k) clearance on 2016-06-07 under 510(k) number K160474. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DSM Biomedical Porcine Pericardium Dental Membrane?

DSM Biomedical Porcine Pericardium Dental Membrane is a medical device that received FDA 510(k) clearance on 2016-06-07. The listed applicant is Kensey Nash Corporation Dba Dsm Biomedical. The 510(k) number is K160474.

When did DSM Biomedical Porcine Pericardium Dental Membrane receive FDA 510(k) clearance?

DSM Biomedical Porcine Pericardium Dental Membrane received FDA 510(k) clearance on 2016-06-07, under 510(k) number K160474.

Who is the listed applicant for DSM Biomedical Porcine Pericardium Dental Membrane?

The FDA 510(k) record lists Kensey Nash Corporation Dba Dsm Biomedical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DSM Biomedical Porcine Pericardium Dental Membrane?

The FDA product code for DSM Biomedical Porcine Pericardium Dental Membrane is NPL.

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Fonte oficial

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