FDA 510(k)

史迪-卡式及史迪-籠消毒包裝系統

K 號：K162063 · 2017-04-21

決定日期2017-04-21

產品代碼KCT

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Steri-Cassette and Steri-Cage Sterilization Packaging System is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Dental Specialties. It received FDA 510(k) clearance on 2017-04-21 under 510(k) number K162063. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Steri-Cassette and Steri-Cage Sterilization Packaging System?

Steri-Cassette and Steri-Cage Sterilization Packaging System is a medical device that received FDA 510(k) clearance on 2017-04-21. The listed applicant is Sybron Dental Specialties. The 510(k) number is K162063.

When did Steri-Cassette and Steri-Cage Sterilization Packaging System receive FDA 510(k) clearance?

Steri-Cassette and Steri-Cage Sterilization Packaging System received FDA 510(k) clearance on 2017-04-21, under 510(k) number K162063.

Who is the listed applicant for Steri-Cassette and Steri-Cage Sterilization Packaging System?

The FDA 510(k) record lists Sybron Dental Specialties as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Steri-Cassette and Steri-Cage Sterilization Packaging System?

The FDA product code for Steri-Cassette and Steri-Cage Sterilization Packaging System is KCT.

其他以 Sybron Dental Specialties 為申請人之記錄

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相關器械（代碼：KCT）

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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