FDA 510(k)

InnoGenic 不吸收性薄膜

K 號：K211554 · 2023-02-24

決定日期2023-02-24

產品代碼NPK

諮詢委員會DE

決定相當於

器材摘要

InnoGenic Non-resorbable Membrane is the device name listed in this FDA 510(k) record. The listed applicant is Cowellmedi Co., Ltd.. It received FDA 510(k) clearance on 2023-02-24 under 510(k) number K211554. The device is classified under product code NPK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the InnoGenic Non-resorbable Membrane?

InnoGenic Non-resorbable Membrane is a medical device that received FDA 510(k) clearance on 2023-02-24. The listed applicant is Cowellmedi Co., Ltd.. The 510(k) number is K211554.

When did InnoGenic Non-resorbable Membrane receive FDA 510(k) clearance?

InnoGenic Non-resorbable Membrane received FDA 510(k) clearance on 2023-02-24, under 510(k) number K211554.

Who is the listed applicant for InnoGenic Non-resorbable Membrane?

The FDA 510(k) record lists Cowellmedi Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InnoGenic Non-resorbable Membrane?

The FDA product code for InnoGenic Non-resorbable Membrane is NPK.

其他以 Cowellmedi Co., Ltd. 為申請人之記錄

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相關器械（代碼：NPK）

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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