FDA 510(k)

ARTOURA 平滑表面乳腺組織擴張器

K 號：K161176 · 2016-05-23

決定日期2016-05-23

產品代碼LCJ

決定相當於

器材摘要

ARTOURA Breast Tissue Expanders with Smooth Surface is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Worldwide, LLC. It received FDA 510(k) clearance on 2016-05-23 under 510(k) number K161176. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

常見問題

What is the ARTOURA Breast Tissue Expanders with Smooth Surface?

ARTOURA Breast Tissue Expanders with Smooth Surface is a medical device that received FDA 510(k) clearance on 2016-05-23. The listed applicant is Mentor Worldwide, LLC. The 510(k) number is K161176.

When did ARTOURA Breast Tissue Expanders with Smooth Surface receive FDA 510(k) clearance?

ARTOURA Breast Tissue Expanders with Smooth Surface received FDA 510(k) clearance on 2016-05-23, under 510(k) number K161176.

Who is the listed applicant for ARTOURA Breast Tissue Expanders with Smooth Surface?

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

What is the FDA product code for ARTOURA Breast Tissue Expanders with Smooth Surface?

The FDA product code for ARTOURA Breast Tissue Expanders with Smooth Surface is LCJ.

其他以 Mentor Worldwide, 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。

K242963MENTOR™ PliaForm™ 乳房組織擴張器配可縫針摺片 K243271MENTOR™記憶形態™可重消毒膠質乳房植入物尺寸計；MENTOR™記憶膠™可重消毒膠質乳房植入物尺寸計；MENTOR™記憶膠™單次使用膠質尺寸計 K243836Mentor™ CPX ™ 4 PLUS Enhance 乳房組織擴張器 K241552MENTOR™ 變形膠體增強單次使用膠體尺寸計 K241918MENTOR™ CPX™4 PLUS Enhance 乳房組織擴張器 K182335CPX 4 平滑表面乳房組織擴張器

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相關器械（代碼：LCJ）

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。

K254126Natrelle 133S 組織擴張器AbbVie K242963MENTOR™ PliaForm™ 乳房組織擴張器配可縫針摺片Mentor Worldwide, LLC K243836Mentor™ CPX ™ 4 PLUS Enhance 乳房組織擴張器Mentor Worldwide, LLC K241918MENTOR™ CPX™4 PLUS Enhance 乳房組織擴張器Mentor Worldwide, LLC K211676Motiva Flora 平滑絲質組織擴張器Motiva USA, LLC K214124AlloX2 Pro組織擴張器Sientra, Inc.

官方來源

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