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FDA 510(k)

ShefaBone SCPC 可吸收骨移植片

K 號:K153230 · 2016-07-14

決定日期2016-07-14
產品代碼LYC
諮詢委員會DE
決定相當於

器材摘要

ShefaBone SCPC Resorbable Bone Graft is the device name listed in this FDA 510(k) record. The listed applicant is The Implantech Inc./Shefabone. It received FDA 510(k) clearance on 2016-07-14 under 510(k) number K153230. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ShefaBone SCPC Resorbable Bone Graft?

ShefaBone SCPC Resorbable Bone Graft is a medical device that received FDA 510(k) clearance on 2016-07-14. The listed applicant is The Implantech Inc./Shefabone. The 510(k) number is K153230.

When did ShefaBone SCPC Resorbable Bone Graft receive FDA 510(k) clearance?

ShefaBone SCPC Resorbable Bone Graft received FDA 510(k) clearance on 2016-07-14, under 510(k) number K153230.

Who is the listed applicant for ShefaBone SCPC Resorbable Bone Graft?

The FDA 510(k) record lists The Implantech Inc./Shefabone as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ShefaBone SCPC Resorbable Bone Graft?

The FDA product code for ShefaBone SCPC Resorbable Bone Graft is LYC.

相關臨床試驗

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相關器械(代碼:LYC)

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。

官方來源

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