FDA 510(k)

Sealapex 管道，Sealapex 散装包装，Sealapex Xpress 双筒注射器

K号: K152959 · 2016-04-14

决定日期2016-04-14

产品代码KIF

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决定实质等同

器械摘要

Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Dental Specialties. It received FDA 510(k) clearance on 2016-04-14 under 510(k) number K152959. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes?

Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes is a medical device that received FDA 510(k) clearance on 2016-04-14. The listed applicant is Sybron Dental Specialties. The 510(k) number is K152959.

When did Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes receive FDA 510(k) clearance?

Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes received FDA 510(k) clearance on 2016-04-14, under 510(k) number K152959.

Who is the listed applicant for Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes?

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

What is the FDA product code for Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes?

The FDA product code for Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes is KIF.

列明Sybron Dental Specialties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。

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