FDA 510(k)

RELiZORB®

K号: K232784 · 2023-12-21

决定日期2023-12-21

产品代码PLQ

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决定实质等同

器械摘要

RELiZORB® is the device name listed in this FDA 510(k) record. The listed applicant is Alcresta Therapeutics, Inc.. It received FDA 510(k) clearance on 2023-12-21 under 510(k) number K232784. The device is classified under product code PLQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RELiZORB®?

RELiZORB® is a medical device that received FDA 510(k) clearance on 2023-12-21. The listed applicant is Alcresta Therapeutics, Inc.. The 510(k) number is K232784.

When did RELiZORB® receive FDA 510(k) clearance?

RELiZORB® received FDA 510(k) clearance on 2023-12-21, under 510(k) number K232784.

Who is the listed applicant for RELiZORB®?

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

What is the FDA product code for RELiZORB®?

The FDA product code for RELiZORB® is PLQ.

列明Alcresta Therapeutics, Inc.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。

K250499RELiZORB (100300/100301)K243284RELiZORB (100300/ 100301)K231156酶填充弹匣 - RELiZORB K191379RELiZORB K163057Relizorb K161247Relizorb

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官方来源

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