FDA 510(k)

Specimen Retrieval Bag

Número K: K172789 · 2018-02-01

RequerenteBeijing Hangtian Kadi Technology R&D Institute

Data da decisão2018-02-01

Código do produtoGCJ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Specimen Retrieval Bag is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Hangtian Kadi Technology R&D Institute. It received FDA 510(k) clearance on 2018-02-01 under 510(k) number K172789. 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 Specimen Retrieval Bag?

Specimen Retrieval Bag is a medical device that received FDA 510(k) clearance on 2018-02-01. The listed applicant is Beijing Hangtian Kadi Technology R&D Institute. The 510(k) number is K172789.

When did Specimen Retrieval Bag receive FDA 510(k) clearance?

Specimen Retrieval Bag received FDA 510(k) clearance on 2018-02-01, under 510(k) number K172789.

Who is the listed applicant for Specimen Retrieval Bag?

The FDA 510(k) record lists Beijing Hangtian Kadi Technology R&D Institute as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Specimen Retrieval Bag?

The FDA product code for Specimen Retrieval Bag is GCJ.

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