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FDA 510(k)

瑞諾生活硬碳塗層鑽頭針

K 號:K151661 · 2016-01-15

決定日期2016-01-15
產品代碼HTW
諮詢委員會或
決定相當於

器材摘要

Renovo Life Hard Carbon Coated Drill Bit is the device name listed in this FDA 510(k) record. The listed applicant is Renovo Life, LLC. It received FDA 510(k) clearance on 2016-01-15 under 510(k) number K151661. The device is classified under product code HTW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Renovo Life Hard Carbon Coated Drill Bit?

Renovo Life Hard Carbon Coated Drill Bit is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is Renovo Life, LLC. The 510(k) number is K151661.

When did Renovo Life Hard Carbon Coated Drill Bit receive FDA 510(k) clearance?

Renovo Life Hard Carbon Coated Drill Bit received FDA 510(k) clearance on 2016-01-15, under 510(k) number K151661.

Who is the listed applicant for Renovo Life Hard Carbon Coated Drill Bit?

The FDA 510(k) record lists Renovo Life, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Renovo Life Hard Carbon Coated Drill Bit?

The FDA product code for Renovo Life Hard Carbon Coated Drill Bit is HTW.

相關臨床試驗

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其他以 Renovo Life, LLC 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。

官方來源

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