FDA 510(k)

Panpac柔性托盘阴道托

K号: K173351 · 2018-10-31

决定日期2018-10-31

产品代码HHW

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决定实质等同

器械摘要

Panpac Flexi Shelf Pessary is the device name listed in this FDA 510(k) record. The listed applicant is Panpac Medical Corporation. It received FDA 510(k) clearance on 2018-10-31 under 510(k) number K173351. The device is classified under product code HHW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Panpac Flexi Shelf Pessary?

Panpac Flexi Shelf Pessary is a medical device that received FDA 510(k) clearance on 2018-10-31. The listed applicant is Panpac Medical Corporation. The 510(k) number is K173351.

When did Panpac Flexi Shelf Pessary receive FDA 510(k) clearance?

Panpac Flexi Shelf Pessary received FDA 510(k) clearance on 2018-10-31, under 510(k) number K173351.

Who is the listed applicant for Panpac Flexi Shelf Pessary?

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

What is the FDA product code for Panpac Flexi Shelf Pessary?

The FDA product code for Panpac Flexi Shelf Pessary is HHW.

列明Panpac Medical Corporation为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K161106PANPAC 可弃真空刮匙 K153422Panpac一次性阴道托植入器套装

官方来源

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