FDA 510(k)

联发安全注射针（五种型号：NPA、PA、PA2、TPA和APA）

K号: K222376 · 2022-10-03

申请人Shandong Lianfa Medical Plastic Products Co. , Ltd.

决定日期2022-10-03

产品代码FMK

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决定实质等同

器械摘要

Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Lianfa Medical Plastic Products Co. , Ltd.. It received FDA 510(k) clearance on 2022-10-03 under 510(k) number K222376. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)?

Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) is a medical device that received FDA 510(k) clearance on 2022-10-03. The listed applicant is Shandong Lianfa Medical Plastic Products Co. , Ltd.. The 510(k) number is K222376.

When did Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) receive FDA 510(k) clearance?

Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) received FDA 510(k) clearance on 2022-10-03, under 510(k) number K222376.

Who is the listed applicant for Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)?

The FDA 510(k) record lists Shandong Lianfa Medical Plastic Products Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)?

The FDA product code for Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) is FMK.

列明Shandong Lianfa Medical Plastic Products Co. , Ltd.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。

K222472刺针系统，一次性无菌 lancet，刺针

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