FDA 510(k)

4plus6Line Abutment System

Número K: K151608 · 2016-04-13

Data da decisão2016-04-13

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

4plus6Line Abutment System is the device name listed in this FDA 510(k) record. The listed applicant is Ot Medical GmbH. It received FDA 510(k) clearance on 2016-04-13 under 510(k) number K151608. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the 4plus6Line Abutment System?

4plus6Line Abutment System is a medical device that received FDA 510(k) clearance on 2016-04-13. The listed applicant is Ot Medical GmbH. The 510(k) number is K151608.

When did 4plus6Line Abutment System receive FDA 510(k) clearance?

4plus6Line Abutment System received FDA 510(k) clearance on 2016-04-13, under 510(k) number K151608.

Who is the listed applicant for 4plus6Line Abutment System?

The FDA 510(k) record lists Ot Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 4plus6Line Abutment System?

The FDA product code for 4plus6Line Abutment System is NHA.

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Fonte oficial

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