FDA 510(k)

DemeTECH PTFE Nonabsorbable Surgical Suture

K号: K181578 · 2018-10-11

决定日期2018-10-11

产品代码NBY

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

DemeTECH PTFE Nonabsorbable Surgical Suture is the device name listed in this FDA 510(k) record. The listed applicant is Demetech Corporation. It received FDA 510(k) clearance on 2018-10-11 under 510(k) number K181578. The device is classified under product code NBY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DemeTECH PTFE Nonabsorbable Surgical Suture?

DemeTECH PTFE Nonabsorbable Surgical Suture is a medical device that received FDA 510(k) clearance on 2018-10-11. The listed applicant is Demetech Corporation. The 510(k) number is K181578.

When did DemeTECH PTFE Nonabsorbable Surgical Suture receive FDA 510(k) clearance?

DemeTECH PTFE Nonabsorbable Surgical Suture received FDA 510(k) clearance on 2018-10-11, under 510(k) number K181578.

Who is the listed applicant for DemeTECH PTFE Nonabsorbable Surgical Suture?

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

What is the FDA product code for DemeTECH PTFE Nonabsorbable Surgical Suture?

The FDA product code for DemeTECH PTFE Nonabsorbable Surgical Suture is NBY.

列明Demetech Corporation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。

K201479DemeMASK K191361DemeDIOX Barbed Absorbable Surgical Suture K190777DemeTECH DemeFORCE Nonabsorbable Surgical Suture K181582DemeTECH DemeDIOX absorbable surgical suture

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。