FDA 510(k)

TIGR 矩阵外科网片, TIGR 外科网片

K号: K191749 · 2020-03-26

决定日期2020-03-26

产品代码OWT

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

TIGR Matrix Surgical Mesh, TIGR Surgical Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Novus Scientific AB. It received FDA 510(k) clearance on 2020-03-26 under 510(k) number K191749. The device is classified under product code OWT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TIGR Matrix Surgical Mesh, TIGR Surgical Mesh?

TIGR Matrix Surgical Mesh, TIGR Surgical Mesh is a medical device that received FDA 510(k) clearance on 2020-03-26. The listed applicant is Novus Scientific AB. The 510(k) number is K191749.

When did TIGR Matrix Surgical Mesh, TIGR Surgical Mesh receive FDA 510(k) clearance?

TIGR Matrix Surgical Mesh, TIGR Surgical Mesh received FDA 510(k) clearance on 2020-03-26, under 510(k) number K191749.

Who is the listed applicant for TIGR Matrix Surgical Mesh, TIGR Surgical Mesh?

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

What is the FDA product code for TIGR Matrix Surgical Mesh, TIGR Surgical Mesh?

The FDA product code for TIGR Matrix Surgical Mesh, TIGR Surgical Mesh is OWT.

列明Novus Scientific AB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。

K163005TIGR 矩阵外科网片

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。