FDA 510(k)

HySil 印模材料

K号: K181236 · 2018-09-13

决定日期2018-09-13

产品代码ELW

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决定实质等同

器械摘要

HySil Impression Materials is the device name listed in this FDA 510(k) record. The listed applicant is Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2018-09-13 under 510(k) number K181236. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HySil Impression Materials?

HySil Impression Materials is a medical device that received FDA 510(k) clearance on 2018-09-13. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K181236.

When did HySil Impression Materials receive FDA 510(k) clearance?

HySil Impression Materials received FDA 510(k) clearance on 2018-09-13, under 510(k) number K181236.

Who is the listed applicant for HySil Impression Materials?

The FDA 510(k) record lists Osstem Implant Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HySil Impression Materials?

The FDA product code for HySil Impression Materials is ELW.

列明Osstem Implant Co., Ltd.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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相关器械（代码：ELW）

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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