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FDA 510(k)

Agulhas de Insulina para Caneta Advocate

Número K: K160199 · 2016-10-19

RequerenteDiabetic Supply of Suncoast, Inc.
Data da decisão2016-10-19
Código do produtoFMI
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

Advocate Insulin Pen Needles is the device name listed in this FDA 510(k) record. The listed applicant is Diabetic Supply of Suncoast, Inc.. It received FDA 510(k) clearance on 2016-10-19 under 510(k) number K160199. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Advocate Insulin Pen Needles?

Advocate Insulin Pen Needles is a medical device that received FDA 510(k) clearance on 2016-10-19. The listed applicant is Diabetic Supply of Suncoast, Inc.. The 510(k) number is K160199.

When did Advocate Insulin Pen Needles receive FDA 510(k) clearance?

Advocate Insulin Pen Needles received FDA 510(k) clearance on 2016-10-19, under 510(k) number K160199.

Who is the listed applicant for Advocate Insulin Pen Needles?

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

What is the FDA product code for Advocate Insulin Pen Needles?

The FDA product code for Advocate Insulin Pen Needles is FMI.

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Dispositivos Relacionados (Código: FMI)

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