FDA 510(k)

维纳斯钻石；维纳斯钻石流；维纳斯珍珠；维纳斯大流量一

K号: K260783 · 2026-03-11

决定日期2026-03-11

产品代码EBF

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决定实质等同

器械摘要

Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One is the device name listed in this FDA 510(k) record. The listed applicant is Kulzer, LLC. It received FDA 510(k) clearance on 2026-03-11 under 510(k) number K260783. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One?

Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One is a medical device that received FDA 510(k) clearance on 2026-03-11. The listed applicant is Kulzer, LLC. The 510(k) number is K260783.

When did Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One receive FDA 510(k) clearance?

Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One received FDA 510(k) clearance on 2026-03-11, under 510(k) number K260783.

Who is the listed applicant for Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One?

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

What is the FDA product code for Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One?

The FDA product code for Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One is EBF.

列明Kulzer, LLC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。

K254063iCEM通用增强型 K243910Retraxil K240660Signum 复合流；Signum 通用粘合剂；Signum 金属粘合剂；Signum 复合；Signum 矩阵；Signum 液体；Signum cre-active K233868迪玛打印牙齿与温度计 K230644Signum 不透明 F K220605维纳斯大流量ONE

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官方来源

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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。