FDA 510(k)

Nucleoss Tpure Implant System

Número K: K160850 · 2017-08-04

RequerenteSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti

Data da decisão2017-08-04

Código do produtoDZE

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Nucleoss Tpure Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti. It received FDA 510(k) clearance on 2017-08-04 under 510(k) number K160850. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Nucleoss Tpure Implant System?

Nucleoss Tpure Implant System is a medical device that received FDA 510(k) clearance on 2017-08-04. The listed applicant is Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti. The 510(k) number is K160850.

When did Nucleoss Tpure Implant System receive FDA 510(k) clearance?

Nucleoss Tpure Implant System received FDA 510(k) clearance on 2017-08-04, under 510(k) number K160850.

Who is the listed applicant for Nucleoss Tpure Implant System?

The FDA 510(k) record lists Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nucleoss Tpure Implant System?

The FDA product code for Nucleoss Tpure Implant System is DZE.

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