FDA 510(k)

巴德3DMax網格

K 號：K233402 · 2023-11-01

申請人Davol Inc., Subsidiary of C. R. Bard, Inc.

決定日期2023-11-01

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

Bard 3DMax Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Davol Inc., Subsidiary of C. R. Bard, Inc.. It received FDA 510(k) clearance on 2023-11-01 under 510(k) number K233402. 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 Bard 3DMax Mesh?

Bard 3DMax Mesh is a medical device that received FDA 510(k) clearance on 2023-11-01. The listed applicant is Davol Inc., Subsidiary of C. R. Bard, Inc.. The 510(k) number is K233402.

When did Bard 3DMax Mesh receive FDA 510(k) clearance?

Bard 3DMax Mesh received FDA 510(k) clearance on 2023-11-01, under 510(k) number K233402.

Who is the listed applicant for Bard 3DMax Mesh?

The FDA 510(k) record lists Davol Inc., Subsidiary of C. R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bard 3DMax Mesh?

The FDA product code for Bard 3DMax Mesh is FTL.

其他以 Davol Inc., Subsidiary of C. R. Bard, 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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