FDA 510(k)

Well-life TM Pen Needles, Well-life TM Safety Pen Needles

N.º K: K210748 · 2022-05-25

Fecha de decisión2022-05-25

Código de productoFMI

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Well-life TM Pen Needles, Well-life TM Safety Pen Needles is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Med Co., Ltd.. It received FDA 510(k) clearance on 2022-05-25 under 510(k) number K210748. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Well-life TM Pen Needles, Well-life TM Safety Pen Needles?

Well-life TM Pen Needles, Well-life TM Safety Pen Needles is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is W. L. Med Co., Ltd.. The 510(k) number is K210748.

When did Well-life TM Pen Needles, Well-life TM Safety Pen Needles receive FDA 510(k) clearance?

Well-life TM Pen Needles, Well-life TM Safety Pen Needles received FDA 510(k) clearance on 2022-05-25, under 510(k) number K210748.

Who is the listed applicant for Well-life TM Pen Needles, Well-life TM Safety Pen Needles?

The FDA 510(k) record lists W. L. Med Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Well-life TM Pen Needles, Well-life TM Safety Pen Needles?

The FDA product code for Well-life TM Pen Needles, Well-life TM Safety Pen Needles is FMI.

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Dispositivos relacionados (Código: FMI)

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Fuente oficial

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