FDA 510(k)

連發安全針筒（五款型號：NPA、PA、PA2、TPA 和 APA）

K 號：K222376 · 2022-10-03

申請人Shandong Lianfa Medical Plastic Products Co. , Ltd.

決定日期2022-10-03

產品代碼FMK

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 Shandong Lianfa Medical Plastic Products Co. , Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K222472穿刺系統，一次性使用无菌針頭，穿刺裝置

相關器械（代碼：FMK）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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