FDA 510(k)

Sientra OPUS矽膠乳房植入體尺寸計

K 號：K200706 · 2020-11-16

決定日期2020-11-16

產品代碼MRD

決定相當於

器材摘要

Sientra OPUS Silicone Gel Breast Implant Sizer is the device name listed in this FDA 510(k) record. The listed applicant is Sientra, Inc.. It received FDA 510(k) clearance on 2020-11-16 under 510(k) number K200706. The device is classified under product code MRD. FDA Decision: Substantially Equivalent.

常見問題

What is the Sientra OPUS Silicone Gel Breast Implant Sizer?

Sientra OPUS Silicone Gel Breast Implant Sizer is a medical device that received FDA 510(k) clearance on 2020-11-16. The listed applicant is Sientra, Inc.. The 510(k) number is K200706.

When did Sientra OPUS Silicone Gel Breast Implant Sizer receive FDA 510(k) clearance?

Sientra OPUS Silicone Gel Breast Implant Sizer received FDA 510(k) clearance on 2020-11-16, under 510(k) number K200706.

Who is the listed applicant for Sientra OPUS Silicone Gel Breast Implant Sizer?

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

What is the FDA product code for Sientra OPUS Silicone Gel Breast Implant Sizer?

The FDA product code for Sientra OPUS Silicone Gel Breast Implant Sizer is MRD.

其他以 Sientra, 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：MRD）

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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