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FDA 510(k)

UNiPACK 隔離袖套及隔離膠膜和 UNiGLIDE 隔離信封

K 號：K183263 · 2019-06-14

申請人Unipack Medical Corporation
決定日期2019-06-14
產品代碼PEM
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

UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope is the device name listed in this FDA 510(k) record. The listed applicant is Unipack Medical Corporation. It received FDA 510(k) clearance on 2019-06-14 under 510(k) number K183263. The device is classified under product code PEM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope?

UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope is a medical device that received FDA 510(k) clearance on 2019-06-14. The listed applicant is Unipack Medical Corporation. The 510(k) number is K183263.

When did UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope receive FDA 510(k) clearance?

UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope received FDA 510(k) clearance on 2019-06-14, under 510(k) number K183263.

Who is the listed applicant for UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope?

The FDA 510(k) record lists Unipack Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope?

The FDA product code for UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope is PEM.

相關臨床試驗

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：PEM）

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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