免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据,仅供一般参考,不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

KeraStat 软膏

K号: K192386 · 2020-07-16

申请人Keranetics
决定日期2020-07-16
产品代码KGN
决定实质等同

器械摘要

KeraStat Cream is the device name listed in this FDA 510(k) record. The listed applicant is Keranetics. It received FDA 510(k) clearance on 2020-07-16 under 510(k) number K192386. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常见问题

What is the KeraStat Cream?

KeraStat Cream is a medical device that received FDA 510(k) clearance on 2020-07-16. The listed applicant is Keranetics. The 510(k) number is K192386.

When did KeraStat Cream receive FDA 510(k) clearance?

KeraStat Cream received FDA 510(k) clearance on 2020-07-16, under 510(k) number K192386.

Who is the listed applicant for KeraStat Cream?

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

What is the FDA product code for KeraStat Cream?

The FDA product code for KeraStat Cream is KGN.

相关临床试验

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。

相关器械(代码:KGN)

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。

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息,请务必参考官方记录。

↑