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FDA 510(k)

Corin 优化定位系统 (OPS) 计划

K号: K183038 · 2018-11-26

申请人Corin USA
决定日期2018-11-26
产品代码LLZ
咨询委员会RA
决定实质等同

器械摘要

Corin Optimized Positioning System (OPS) Plan is the device name listed in this FDA 510(k) record. The listed applicant is Corin USA. It received FDA 510(k) clearance on 2018-11-26 under 510(k) number K183038. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Corin Optimized Positioning System (OPS) Plan?

Corin Optimized Positioning System (OPS) Plan is a medical device that received FDA 510(k) clearance on 2018-11-26. The listed applicant is Corin USA. The 510(k) number is K183038.

When did Corin Optimized Positioning System (OPS) Plan receive FDA 510(k) clearance?

Corin Optimized Positioning System (OPS) Plan received FDA 510(k) clearance on 2018-11-26, under 510(k) number K183038.

Who is the listed applicant for Corin Optimized Positioning System (OPS) Plan?

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

What is the FDA product code for Corin Optimized Positioning System (OPS) Plan?

The FDA product code for Corin Optimized Positioning System (OPS) Plan is LLZ.

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列明Corin USA为申报人的其他记录

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相关器械(代码:LLZ)

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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