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FDA 510(k)

Dermatac™ 折邊與V.A.C. Granufoam 敷料，配備SensaT.R.A.C. 技術-小號（5入），Dermatac 折邊與V.A.C. Granufoam 敷料，配備SensaT.R.A.C. 技術 -小號（10入），Dermatac 折邊與V.A.C. Granufoam 敷料，配備SensaT.R.A.C. 技術 -中號（5入），Dermatac 折邊與V.A.C. Granufoam 敷料，配備SensaT.R.A.C. 技術 -中號（10入），Dermatac 折邊與V.A.C. Granufoam 敷料，配備SensaT.R.A.C. 技術- 大號（5入）

K 號：K212320 · 2021-09-28

申請人3M Healthcare Business Group
決定日期2021-09-28
產品代碼OMP
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

Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac is the device name listed in this FDA 510(k) record. The listed applicant is 3M Healthcare Business Group. It received FDA 510(k) clearance on 2021-09-28 under 510(k) number K212320. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac?

Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac is a medical device that received FDA 510(k) clearance on 2021-09-28. The listed applicant is 3M Healthcare Business Group. The 510(k) number is K212320.

When did Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac receive FDA 510(k) clearance?

Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac received FDA 510(k) clearance on 2021-09-28, under 510(k) number K212320.

Who is the listed applicant for Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac?

The FDA 510(k) record lists 3M Healthcare Business Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac?

The FDA product code for Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac is OMP.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 3M Healthcare Business Group 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。

K2215853M V.A.C. Veraflo 清洁选择敷料套装，3M Veraflo 清洁选择完整敷料套装K220660Prevena Restor 適應形態敷料K210135PROMOGRAN PRISMA 矩陣，小型敷料，PROMOGRAN PRISMA 矩陣，大型敷料K2115213M Veraflo 清洁选择完整敷料套装（中型敷料套装：VFCCC05MD，大型敷料套装：VFCCC05LG）

相關器械（代碼：OMP）

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。

K261338RENASYS DYNAFLOW 套件（66807741）Smith & Nephew Medical, Ltd.K253263ConvaVAC™ 負壓傷口治療系統Convatec Limited, Gdc BuildingK253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT 內容器 500-mL (CPC-500)Cork MedicalK254019傷口基因NPWT系統Bechtel Medical, Inc.

官方來源

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