FDA 510(k)

StaClear Syringe

Número K: K200242 · 2020-07-27

Data da decisão2020-07-27

Código do produtoQLY

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

StaClear Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Tribofilm Research, Inc.. It received FDA 510(k) clearance on 2020-07-27 under 510(k) number K200242. The device is classified under product code QLY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the StaClear Syringe?

StaClear Syringe is a medical device that received FDA 510(k) clearance on 2020-07-27. The listed applicant is Tribofilm Research, Inc.. The 510(k) number is K200242.

When did StaClear Syringe receive FDA 510(k) clearance?

StaClear Syringe received FDA 510(k) clearance on 2020-07-27, under 510(k) number K200242.

Who is the listed applicant for StaClear Syringe?

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

What is the FDA product code for StaClear Syringe?

The FDA product code for StaClear Syringe is QLY.

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Dispositivos Relacionados (Código: QLY)

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Fonte oficial

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