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FDA 510(k)

KTA脂肪治療套件

K 號:K190386 · 2019-10-10

申請人Stemics S.A.S
決定日期2019-10-10
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

KTA Adipose Treatment Kit is the device name listed in this FDA 510(k) record. The listed applicant is Stemics S.A.S. It received FDA 510(k) clearance on 2019-10-10 under 510(k) number K190386. 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 KTA Adipose Treatment Kit?

KTA Adipose Treatment Kit is a medical device that received FDA 510(k) clearance on 2019-10-10. The listed applicant is Stemics S.A.S. The 510(k) number is K190386.

When did KTA Adipose Treatment Kit receive FDA 510(k) clearance?

KTA Adipose Treatment Kit received FDA 510(k) clearance on 2019-10-10, under 510(k) number K190386.

Who is the listed applicant for KTA Adipose Treatment Kit?

The FDA 510(k) record lists Stemics S.A.S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KTA Adipose Treatment Kit?

The FDA product code for KTA Adipose Treatment Kit is MUU.

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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。

官方來源

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