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FDA 510(k)

遞送應用器中的無機骨礦物質與膠原蛋白

K 號：K171008 · 2017-10-30

申請人Collagen Matrix, Inc.
決定日期2017-10-30
產品代碼NPM
諮詢委員會DE
決定相當於

器材摘要

Anorganic Bone Mineral with Collagen in Delivery Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Collagen Matrix, Inc.. It received FDA 510(k) clearance on 2017-10-30 under 510(k) number K171008. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Anorganic Bone Mineral with Collagen in Delivery Applicator?

Anorganic Bone Mineral with Collagen in Delivery Applicator is a medical device that received FDA 510(k) clearance on 2017-10-30. The listed applicant is Collagen Matrix, Inc.. The 510(k) number is K171008.

When did Anorganic Bone Mineral with Collagen in Delivery Applicator receive FDA 510(k) clearance?

Anorganic Bone Mineral with Collagen in Delivery Applicator received FDA 510(k) clearance on 2017-10-30, under 510(k) number K171008.

Who is the listed applicant for Anorganic Bone Mineral with Collagen in Delivery Applicator?

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

What is the FDA product code for Anorganic Bone Mineral with Collagen in Delivery Applicator?

The FDA product code for Anorganic Bone Mineral with Collagen in Delivery Applicator is NPM.

相關臨床試驗

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NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Collagen Matrix, 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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相關器械（代碼：NPM）

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。

K254210REBOHIL（BGM-1、BGM-2、BGM-3、BGM-4、BGM-5）Hyundai Bioland Co., Ltd.K253723BOSSMedpark Co., Ltd.K251786Geistlich Bio-Oss®；Geistlich Bio-Oss Pen®Geistlich Pharma AGK251613瑞士移植XGeistlich Pharma AGK242510Geistlich 生物流®Geistlich Pharma AGK240133異種移植牛骨微粒Collagen Solutions, LLC

官方來源

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