FDA 510(k)

3M 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）

K 號：K211521 · 2021-12-20

決定日期2021-12-20

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

3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG) 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 2021-12-20 under 510(k) number K211521. 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 3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG)?

3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG) is a medical device that received FDA 510(k) clearance on 2021-12-20. The listed applicant is 3M Healthcare Business Group. The 510(k) number is K211521.

When did 3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG) receive FDA 510(k) clearance?

3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG) received FDA 510(k) clearance on 2021-12-20, under 510(k) number K211521.

Who is the listed applicant for 3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG)?

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 3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG)?

The FDA product code for 3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG) is OMP.

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 K212320Dermatac™ 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）

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。

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官方來源

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