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FDA 510(k)

精密醫療克氏針

K 號:K163327 · 2017-05-08

決定日期2017-05-08
產品代碼HTY
諮詢委員會或
決定相當於

器材摘要

Precifit Medical Kirschner Wires is the device name listed in this FDA 510(k) record. The listed applicant is Precifit Medical, Ltd.. It received FDA 510(k) clearance on 2017-05-08 under 510(k) number K163327. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Precifit Medical Kirschner Wires?

Precifit Medical Kirschner Wires is a medical device that received FDA 510(k) clearance on 2017-05-08. The listed applicant is Precifit Medical, Ltd.. The 510(k) number is K163327.

When did Precifit Medical Kirschner Wires receive FDA 510(k) clearance?

Precifit Medical Kirschner Wires received FDA 510(k) clearance on 2017-05-08, under 510(k) number K163327.

Who is the listed applicant for Precifit Medical Kirschner Wires?

The FDA 510(k) record lists Precifit Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Precifit Medical Kirschner Wires?

The FDA product code for Precifit Medical Kirschner Wires is HTY.

相關臨床試驗

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其他以 Precifit Medical, Ltd. 為申請人之記錄

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相關器械(代碼:HTY)

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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