FDA 510(k)

PF保持；CAD CAM保持塊

K 號：K233171 · 2023-11-27

決定日期2023-11-27

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

PF Keep; Cad Cam Keep Block is the device name listed in this FDA 510(k) record. The listed applicant is Clemde SA DE CV. It received FDA 510(k) clearance on 2023-11-27 under 510(k) number K233171. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PF Keep; Cad Cam Keep Block?

PF Keep; Cad Cam Keep Block is a medical device that received FDA 510(k) clearance on 2023-11-27. The listed applicant is Clemde SA DE CV. The 510(k) number is K233171.

When did PF Keep; Cad Cam Keep Block receive FDA 510(k) clearance?

PF Keep; Cad Cam Keep Block received FDA 510(k) clearance on 2023-11-27, under 510(k) number K233171.

Who is the listed applicant for PF Keep; Cad Cam Keep Block?

The FDA 510(k) record lists Clemde SA DE CV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PF Keep; Cad Cam Keep Block?

The FDA product code for PF Keep; Cad Cam Keep Block is EBI.

其他以 Clemde SA DE CV 為申請人之記錄

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K242897部分柔軟

相關器械（代碼：EBI）

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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