FDA 510(k)

THE 覆蓋

K 號：K230091 · 2023-10-06

決定日期2023-10-06

產品代碼NPL

諮詢委員會DE

決定相當於

器材摘要

THE Cover is the device name listed in this FDA 510(k) record. The listed applicant is Purgo Biologics, Inc.. It received FDA 510(k) clearance on 2023-10-06 under 510(k) number K230091. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the THE Cover?

THE Cover is a medical device that received FDA 510(k) clearance on 2023-10-06. The listed applicant is Purgo Biologics, Inc.. The 510(k) number is K230091.

When did THE Cover receive FDA 510(k) clearance?

THE Cover received FDA 510(k) clearance on 2023-10-06, under 510(k) number K230091.

Who is the listed applicant for THE Cover?

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

What is the FDA product code for THE Cover?

The FDA product code for THE Cover is NPL.

其他以 Purgo Biologics, Inc. 為申請人之記錄

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相關器械（代碼：NPL）

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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