FDA 510(k)

自保持拉開器

K 號：K161004 · 2016-09-09

決定日期2016-09-09

產品代碼GZT

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Self-retaining Retractor is the device name listed in this FDA 510(k) record. The listed applicant is Fetzer Medical GmbH & Co. KG. It received FDA 510(k) clearance on 2016-09-09 under 510(k) number K161004. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Self-retaining Retractor?

Self-retaining Retractor is a medical device that received FDA 510(k) clearance on 2016-09-09. The listed applicant is Fetzer Medical GmbH & Co. KG. The 510(k) number is K161004.

When did Self-retaining Retractor receive FDA 510(k) clearance?

Self-retaining Retractor received FDA 510(k) clearance on 2016-09-09, under 510(k) number K161004.

Who is the listed applicant for Self-retaining Retractor?

The FDA 510(k) record lists Fetzer Medical GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Self-retaining Retractor?

The FDA product code for Self-retaining Retractor is GZT.

其他以 Fetzer Medical GmbH & Co. KG 為申請人之記錄

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：GZT）

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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