FDA 510(k)

PDO Max 經緯針，雙針設計

K 號：K210871 · 2021-12-17

決定日期2021-12-17

產品代碼NEW

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

PDO Max Suture with Dual Needle is the device name listed in this FDA 510(k) record. The listed applicant is Pdo Max, Inc.. It received FDA 510(k) clearance on 2021-12-17 under 510(k) number K210871. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PDO Max Suture with Dual Needle?

PDO Max Suture with Dual Needle is a medical device that received FDA 510(k) clearance on 2021-12-17. The listed applicant is Pdo Max, Inc.. The 510(k) number is K210871.

When did PDO Max Suture with Dual Needle receive FDA 510(k) clearance?

PDO Max Suture with Dual Needle received FDA 510(k) clearance on 2021-12-17, under 510(k) number K210871.

Who is the listed applicant for PDO Max Suture with Dual Needle?

The FDA 510(k) record lists Pdo Max, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PDO Max Suture with Dual Needle?

The FDA product code for PDO Max Suture with Dual Needle is NEW.

其他以 Pdo Max, Inc. 為申請人之記錄

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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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