FDA 510(k)

THE Cover

K号: K230091 · 2023-10-06

决定日期2023-10-06

产品代码NPL

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决定实质等同

器械摘要

THE Cover is the device name listed in this FDA 510(k) record. The listed applicant is Purgo Biologics, Inc.. It received FDA 510(k) clearance on 2023-10-06 under 510(k) number K230091. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the THE Cover?

THE Cover is a medical device that received FDA 510(k) clearance on 2023-10-06. The listed applicant is Purgo Biologics, Inc.. The 510(k) number is K230091.

When did THE Cover receive FDA 510(k) clearance?

THE Cover received FDA 510(k) clearance on 2023-10-06, under 510(k) number K230091.

Who is the listed applicant for THE Cover?

The FDA 510(k) record lists Purgo Biologics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE Cover?

The FDA product code for THE Cover is NPL.

列明Purgo Biologics, 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。

K230305THE Graft Collagen K222549OpenTex K191737移植物骨替代品 K180992Biotex K173188移植物天然骨替代品

相关器械（代码：NPL）

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。

K242817Jason 膜Botiss Biomaterials GmbH K250512增强牙龈基质Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.K252253Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®Geistlich Pharma AG K251062Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi PackGeistlich Pharma AG K250833SwissMembrane X；SwissMembrane X 插座Geistlich Pharma AG K233203软组织增强可吸收基质Collagen Matrix, Inc.

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