FDA 510(k)

Exofin 高粘度局部皮膚膠粘劑

K 號：K200264 · 2020-12-17

決定日期2020-12-17

產品代碼MPN

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Exofin High Viscosity Topical Skin Adhesive is the device name listed in this FDA 510(k) record. The listed applicant is Chemence Medical, Inc.. It received FDA 510(k) clearance on 2020-12-17 under 510(k) number K200264. The device is classified under product code MPN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Exofin High Viscosity Topical Skin Adhesive?

Exofin High Viscosity Topical Skin Adhesive is a medical device that received FDA 510(k) clearance on 2020-12-17. The listed applicant is Chemence Medical, Inc.. The 510(k) number is K200264.

When did Exofin High Viscosity Topical Skin Adhesive receive FDA 510(k) clearance?

Exofin High Viscosity Topical Skin Adhesive received FDA 510(k) clearance on 2020-12-17, under 510(k) number K200264.

Who is the listed applicant for Exofin High Viscosity Topical Skin Adhesive?

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

What is the FDA product code for Exofin High Viscosity Topical Skin Adhesive?

The FDA product code for Exofin High Viscosity Topical Skin Adhesive is MPN.

其他以 Chemence Medical, 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。

K212246Exofin精準筆 K191461Exofin 融合皮膚閉合系統 K171442Exofin 融合皮膚閉合系統 K162352derma+flex QS 高濃度組織膠粘劑

相關器械（代碼：MPN）

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。

K243990BondEase 2 開放性皮膚膠粘劑Optmed, Inc.K250950CUTIVA™皮膚外用膠粘劑（RM1700）；CUTIVA™ PLUS皮膚閉合系統（RM1739）Okapi Medical, LLC Dba Resivant Medical K234114CUTIVA™皮膚外用膠粘劑（RM-1700）；CUTIVA™ PLUS皮膚閉合系統（RM-1739）Okapi Medical, LLC Dba Resivant Medical K233458CM005標準型 (CM005)；CM004迷你型 (CM004)Connexicon Medical , Ltd.K230981美瑞光局部皮膚膠粘劑M/s. Meril Endo Surgery Private Limited.K212246Exofin精準筆Chemence Medical, Inc.

官方來源

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