FDA 510(k)

GORE SYNECOR 間腹腔生物材質

K 號：K163576 · 2017-05-11

決定日期2017-05-11

產品代碼FTL

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

GORE SYNECOR Preperitoneal Biomaterial is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2017-05-11 under 510(k) number K163576. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the GORE SYNECOR Preperitoneal Biomaterial?

GORE SYNECOR Preperitoneal Biomaterial is a medical device that received FDA 510(k) clearance on 2017-05-11. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K163576.

When did GORE SYNECOR Preperitoneal Biomaterial receive FDA 510(k) clearance?

GORE SYNECOR Preperitoneal Biomaterial received FDA 510(k) clearance on 2017-05-11, under 510(k) number K163576.

Who is the listed applicant for GORE SYNECOR Preperitoneal Biomaterial?

The FDA 510(k) record lists W. L. Gore & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GORE SYNECOR Preperitoneal Biomaterial?

The FDA product code for GORE SYNECOR Preperitoneal Biomaterial is FTL.

其他以 W. L. Gore & Associates, Inc. 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：FTL）

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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