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FDA 510(k)

Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection

Número K: K232046 · 2023-10-06

RequerenteXeridiem Medical Devices, A Spectrum Plastics Group Company
Data da decisão2023-10-06
Código do produtoPIF
Comité consultivoGU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection is the device name listed in this FDA 510(k) record. The listed applicant is Xeridiem Medical Devices, A Spectrum Plastics Group Company. It received FDA 510(k) clearance on 2023-10-06 under 510(k) number K232046. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection?

Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection is a medical device that received FDA 510(k) clearance on 2023-10-06. The listed applicant is Xeridiem Medical Devices, A Spectrum Plastics Group Company. The 510(k) number is K232046.

When did Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection receive FDA 510(k) clearance?

Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection received FDA 510(k) clearance on 2023-10-06, under 510(k) number K232046.

Who is the listed applicant for Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection?

The FDA 510(k) record lists Xeridiem Medical Devices, A Spectrum Plastics Group Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection?

The FDA product code for Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection is PIF.

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Dispositivos Relacionados (Código: PIF)

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Fonte oficial

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