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FDA 510(k)

袋鼠皮層氣囊胃造口套件,帶ENFIT連接的袋鼠湯團輸送組,帶ENFIT連接的袋鼠持續輸送組

K 號:K232046 · 2023-10-06

決定日期2023-10-06
產品代碼PIF
諮詢委員會GU
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

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其他以 Xeridiem Medical Devices, A Spectrum Plastics Group Company 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

相關器械(代碼:PIF)

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

官方來源

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