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FDA 510(k)

HealiAid 牙科胶原蛋白伤口敷料

K号: K230529 · 2023-11-22

决定日期2023-11-22
产品代码OLR
决定实质等同

器械摘要

HealiAid Dental Collagen Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Maxigen Biotech, Inc.. It received FDA 510(k) clearance on 2023-11-22 under 510(k) number K230529. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

常见问题

What is the HealiAid Dental Collagen Wound Dressing?

HealiAid Dental Collagen Wound Dressing is a medical device that received FDA 510(k) clearance on 2023-11-22. The listed applicant is Maxigen Biotech, Inc.. The 510(k) number is K230529.

When did HealiAid Dental Collagen Wound Dressing receive FDA 510(k) clearance?

HealiAid Dental Collagen Wound Dressing received FDA 510(k) clearance on 2023-11-22, under 510(k) number K230529.

Who is the listed applicant for HealiAid Dental Collagen Wound Dressing?

FDA 510(k)记录中列出Maxigen Biotech, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for HealiAid Dental Collagen Wound Dressing?

The FDA product code for HealiAid Dental Collagen Wound Dressing is OLR.

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。

列明Maxigen Biotech, 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。

相关器械(代码:OLR)

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。

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