FDA 510(k)

Medline Sure-Snap安全注射针，Medline Sure-Snap安全注射器

K号: K213054 · 2022-12-09

决定日期2022-12-09

产品代码FMF

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe 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 2022-12-09 under 510(k) number K213054. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe?

Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe is a medical device that received FDA 510(k) clearance on 2022-12-09. The listed applicant is Medline Industries, Inc.. The 510(k) number is K213054.

When did Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe receive FDA 510(k) clearance?

Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe received FDA 510(k) clearance on 2022-12-09, under 510(k) number K213054.

Who is the listed applicant for Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe?

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 Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe?

The FDA product code for Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe is FMF.

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。

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相关器械（代码：FMF）

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。

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官方来源

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