FDA 510(k)

GORE BIO-A 组织加强

K号: K191773 · 2019-07-31

决定日期2019-07-31

产品代码OWT

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决定实质等同

器械摘要

GORE BIO-A Tissue Reinforcement is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2019-07-31 under 510(k) number K191773. 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 GORE BIO-A Tissue Reinforcement?

GORE BIO-A Tissue Reinforcement is a medical device that received FDA 510(k) clearance on 2019-07-31. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K191773.

When did GORE BIO-A Tissue Reinforcement receive FDA 510(k) clearance?

GORE BIO-A Tissue Reinforcement received FDA 510(k) clearance on 2019-07-31, under 510(k) number K191773.

Who is the listed applicant for GORE BIO-A Tissue Reinforcement?

The FDA 510(k) record lists W. L. Gore & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GORE BIO-A Tissue Reinforcement?

The FDA product code for GORE BIO-A Tissue Reinforcement is OWT.

列明W. L. Gore & Associates, Inc.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。

K250410GORE® 三叶球囊导管 K240083GORE® PROPATEN® 血管移植物 K232312GORE® PROPATEN® 血管移植物 K233551GORE® ACUSEAL 血管移植物 K231505GORE® ACUSEAL 血管移植物 K222919GORE® ENFORM 生物材料

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官方来源

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