FDA 510(k)

UNiPACK 隔离套筒和隔离薄膜以及 UNiGLIDE 隔离信封

K号: K183263 · 2019-06-14

决定日期2019-06-14

产品代码PEM

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决定实质等同

器械摘要

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.

常见问题

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.

官方来源

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UNiPACK 隔离套筒和隔离薄膜以及 UNiGLIDE 隔离信封

器械摘要

常见问题

相关临床试验

相关器械（代码：PEM）

官方来源