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FDA 510(k)

IntelliFat 一次性脂肪組織採集及轉移套件，IntelliFat 需求時體內脂肪（BOD）套件

K 號：K210528 · 2022-03-16

申請人Millennium Medical Technologies Inc (Dba Cellmyx)
決定日期2022-03-16
產品代碼MUU
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit is the device name listed in this FDA 510(k) record. The listed applicant is Millennium Medical Technologies Inc (Dba Cellmyx). It received FDA 510(k) clearance on 2022-03-16 under 510(k) number K210528. The device is classified under product code MUU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit?

IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit is a medical device that received FDA 510(k) clearance on 2022-03-16. The listed applicant is Millennium Medical Technologies Inc (Dba Cellmyx). The 510(k) number is K210528.

When did IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit receive FDA 510(k) clearance?

IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit received FDA 510(k) clearance on 2022-03-16, under 510(k) number K210528.

Who is the listed applicant for IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit?

The FDA 510(k) record lists Millennium Medical Technologies Inc (Dba Cellmyx) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit?

The FDA product code for IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit is MUU.

相關臨床試驗

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。

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相關器械（代碼：MUU）

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。

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官方來源

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