FDA 510(k)

Parietene DS 复合网

K号: K163212 · 2017-06-29

决定日期2017-06-29

产品代码FTL

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决定实质等同

器械摘要

Parietene DS Composite Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Sofradim Production. It received FDA 510(k) clearance on 2017-06-29 under 510(k) number K163212. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Parietene DS Composite Mesh?

Parietene DS Composite Mesh is a medical device that received FDA 510(k) clearance on 2017-06-29. The listed applicant is Sofradim Production. The 510(k) number is K163212.

When did Parietene DS Composite Mesh receive FDA 510(k) clearance?

Parietene DS Composite Mesh received FDA 510(k) clearance on 2017-06-29, under 510(k) number K163212.

Who is the listed applicant for Parietene DS Composite Mesh?

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

What is the FDA product code for Parietene DS Composite Mesh?

The FDA product code for Parietene DS Composite Mesh is FTL.

列明Sofradim Production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。

K253956ProGrip™ 高级自粘聚丙烯网眼布 (ADG1510, ADG2015, ADG3020, ADG4030)K250869Parietene® Macroporous 网格 (PPM5050 )K243315ProGrip™ 自粘聚丙烯网眼布 K233661Transorb™ 自粘性可吸收网 K232373Progrip® 自锁聚丙烯网 K223218Parietene Macroporous 网格

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