FDA 510(k)

Medline 普通外科托盘

K号: K213481 · 2022-05-24

决定日期2022-05-24

产品代码LRO

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决定实质等同

器械摘要

Medline General Surgery Tray is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2022-05-24 under 510(k) number K213481. The device is classified under product code LRO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Medline General Surgery Tray?

Medline General Surgery Tray is a medical device that received FDA 510(k) clearance on 2022-05-24. The listed applicant is Medline Industries, Inc.. The 510(k) number is K213481.

When did Medline General Surgery Tray receive FDA 510(k) clearance?

Medline General Surgery Tray received FDA 510(k) clearance on 2022-05-24, under 510(k) number K213481.

Who is the listed applicant for Medline General Surgery Tray?

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

What is the FDA product code for Medline General Surgery Tray?

The FDA product code for Medline General Surgery Tray is LRO.

列明Medline Industries, 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。

K230559Hudson RCI® 4 PSI 压力释放阀的 disposable 加湿器（3230），Hudson RCI® 6 PSI 压力释放阀的 disposable 加湿器（3260）K223100Hudson RCI AquaTherm III Plus 外部可调电子加热器（050-14）K222665Medline UNITE® 踝关节融合接骨板系统 K213054Medline Sure-Snap安全注射针，Medline Sure-Snap安全注射器 K212911Konig Mogen 夹 K220565Hudson RCI Triflo II 激励深呼吸训练器

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官方来源

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