FDA 510(k)

ETIII SA 固定系统（O3.2mm）

K号: K153332 · 2016-10-27

决定日期2016-10-27

产品代码DZE

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决定实质等同

器械摘要

ETIII SA Fixture System (O3.2mm) is the device name listed in this FDA 510(k) record. The listed applicant is Hiossen, Inc.. It received FDA 510(k) clearance on 2016-10-27 under 510(k) number K153332. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ETIII SA Fixture System (O3.2mm)?

ETIII SA Fixture System (O3.2mm) is a medical device that received FDA 510(k) clearance on 2016-10-27. The listed applicant is Hiossen, Inc.. The 510(k) number is K153332.

When did ETIII SA Fixture System (O3.2mm) receive FDA 510(k) clearance?

ETIII SA Fixture System (O3.2mm) received FDA 510(k) clearance on 2016-10-27, under 510(k) number K153332.

Who is the listed applicant for ETIII SA Fixture System (O3.2mm)?

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

What is the FDA product code for ETIII SA Fixture System (O3.2mm)?

The FDA product code for ETIII SA Fixture System (O3.2mm) is DZE.

列明Hiossen, 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。

K253372ET修复连接体；ET扫描修复连接体；EK扫描修复连接体 K251427EK MULTI ANGLED 30 基台 K241003HIOSSEN 预加工基台（ET 预加工基台 & EK 预加工基台）K240232EK D3.3 和超宽植入物 K233389EK 数字基台 K222636ET连接体系统

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官方来源

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