FDA 510(k)

Pledgeted COR-SUTURE QUICK LOAD

Número K: K160529 · 2016-09-15

Data da decisão2016-09-15

Código do produtoGAW

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pledgeted COR-SUTURE QUICK LOAD is the device name listed in this FDA 510(k) record. The listed applicant is Lsi Soultions. It received FDA 510(k) clearance on 2016-09-15 under 510(k) number K160529. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Pledgeted COR-SUTURE QUICK LOAD?

Pledgeted COR-SUTURE QUICK LOAD is a medical device that received FDA 510(k) clearance on 2016-09-15. The listed applicant is Lsi Soultions. The 510(k) number is K160529.

When did Pledgeted COR-SUTURE QUICK LOAD receive FDA 510(k) clearance?

Pledgeted COR-SUTURE QUICK LOAD received FDA 510(k) clearance on 2016-09-15, under 510(k) number K160529.

Who is the listed applicant for Pledgeted COR-SUTURE QUICK LOAD?

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

What is the FDA product code for Pledgeted COR-SUTURE QUICK LOAD?

The FDA product code for Pledgeted COR-SUTURE QUICK LOAD is GAW.

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