FDA 510(k)

LiVac Retractor System

Número K: K162445 · 2016-10-20

Data da decisão2016-10-20

Código do produtoGCJ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

LiVac Retractor System is the device name listed in this FDA 510(k) record. The listed applicant is Livac Pty, Ltd.. It received FDA 510(k) clearance on 2016-10-20 under 510(k) number K162445. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LiVac Retractor System?

LiVac Retractor System is a medical device that received FDA 510(k) clearance on 2016-10-20. The listed applicant is Livac Pty, Ltd.. The 510(k) number is K162445.

When did LiVac Retractor System receive FDA 510(k) clearance?

LiVac Retractor System received FDA 510(k) clearance on 2016-10-20, under 510(k) number K162445.

Who is the listed applicant for LiVac Retractor System?

The FDA 510(k) record lists Livac Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LiVac Retractor System?

The FDA product code for LiVac Retractor System is GCJ.

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