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FDA 510(k)

Bonus Therapeutics Mixing and Delivery System

Número K: K190996 · 2019-07-28

RequerenteBonus Therapeutics , Ltd.
Data da decisão2019-07-28
Código do produtoFMF
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

Bonus Therapeutics Mixing and Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Bonus Therapeutics , Ltd.. It received FDA 510(k) clearance on 2019-07-28 under 510(k) number K190996. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Bonus Therapeutics Mixing and Delivery System?

Bonus Therapeutics Mixing and Delivery System is a medical device that received FDA 510(k) clearance on 2019-07-28. The listed applicant is Bonus Therapeutics , Ltd.. The 510(k) number is K190996.

When did Bonus Therapeutics Mixing and Delivery System receive FDA 510(k) clearance?

Bonus Therapeutics Mixing and Delivery System received FDA 510(k) clearance on 2019-07-28, under 510(k) number K190996.

Who is the listed applicant for Bonus Therapeutics Mixing and Delivery System?

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

What is the FDA product code for Bonus Therapeutics Mixing and Delivery System?

The FDA product code for Bonus Therapeutics Mixing and Delivery System is FMF.

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