FDA 510(k)

derma+flex QS 高濃度組織膠粘劑

K 號：K162352 · 2016-12-22

決定日期2016-12-22

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

derma+flex QS High Viscosity Tissue 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 2016-12-22 under 510(k) number K162352. 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 derma+flex QS High Viscosity Tissue Adhesive?

derma+flex QS High Viscosity Tissue Adhesive is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Chemence Medical, Inc.. The 510(k) number is K162352.

When did derma+flex QS High Viscosity Tissue Adhesive receive FDA 510(k) clearance?

derma+flex QS High Viscosity Tissue Adhesive received FDA 510(k) clearance on 2016-12-22, under 510(k) number K162352.

Who is the listed applicant for derma+flex QS High Viscosity Tissue 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 derma+flex QS High Viscosity Tissue Adhesive?

The FDA product code for derma+flex QS High Viscosity Tissue 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。

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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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