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FDA 510(k)

Portex® 鋸刺點脊椎針配NRFit™ 插頭，Portex® 圆錐點脊椎針配NRFit™ 插頭

K 號：K172800 · 2018-06-14

申請人Smiths Medical Asd, Inc.
決定日期2018-06-14
產品代碼MIA
諮詢委員會AN
決定相當於

器材摘要

Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2018-06-14 under 510(k) number K172800. The device is classified under product code MIA. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors?

Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors is a medical device that received FDA 510(k) clearance on 2018-06-14. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K172800.

When did Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors receive FDA 510(k) clearance?

Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors received FDA 510(k) clearance on 2018-06-14, under 510(k) number K172800.

Who is the listed applicant for Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors?

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

What is the FDA product code for Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors?

The FDA product code for Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors is MIA.

相關臨床試驗

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其他以 Smiths Medical Asd, Inc. 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。

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