FDA 510(k)

DemeTECH DemeFORCE Nonabsorbable Surgical Suture

K号: K190777 · 2019-07-31

决定日期2019-07-31

产品代码GAT

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决定实质等同

器械摘要

DemeTECH DemeFORCE 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 2019-07-31 under 510(k) number K190777. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DemeTECH DemeFORCE Nonabsorbable Surgical Suture?

DemeTECH DemeFORCE Nonabsorbable Surgical Suture is a medical device that received FDA 510(k) clearance on 2019-07-31. The listed applicant is Demetech Corporation. The 510(k) number is K190777.

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

DemeTECH DemeFORCE Nonabsorbable Surgical Suture received FDA 510(k) clearance on 2019-07-31, under 510(k) number K190777.

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

The FDA product code for DemeTECH DemeFORCE Nonabsorbable Surgical Suture is GAT.

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 K181578DemeTECH PTFE Nonabsorbable Surgical Suture K181582DemeTECH DemeDIOX absorbable surgical suture

官方来源

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