FDA 510(k)

TIGR 矩阵外科网片

K号: K163005 · 2017-07-27

决定日期2017-07-27

产品代码OWT

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决定实质等同

器械摘要

TIGR Matrix 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 2017-07-27 under 510(k) number K163005. 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 Matrix Surgical Mesh is a medical device that received FDA 510(k) clearance on 2017-07-27. The listed applicant is Novus Scientific AB. The 510(k) number is K163005.

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

TIGR Matrix Surgical Mesh received FDA 510(k) clearance on 2017-07-27, under 510(k) number K163005.

Who is the listed applicant for TIGR Matrix 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?

The FDA product code for TIGR Matrix 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。

K191749TIGR 矩阵外科网片, TIGR 外科网片

官方来源

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