FDA 510(k)

MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle

Número K: K172775 · 2018-02-12

Data da decisão2018-02-12

Código do produtoOCW

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2018-02-12 under 510(k) number K172775. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle?

MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle is a medical device that received FDA 510(k) clearance on 2018-02-12. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K172775.

When did MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle receive FDA 510(k) clearance?

MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle received FDA 510(k) clearance on 2018-02-12, under 510(k) number K172775.

Who is the listed applicant for MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle?

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

What is the FDA product code for MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle?

The FDA product code for MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle is OCW.

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Fonte oficial

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