FDA 510(k)

Cavilon先進高耐久皮膚保護劑

K 號：K153571 · 2016-08-23

決定日期2016-08-23

產品代碼KMF

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Cavilon Advanced High Endurance Skin Protectant is the device name listed in this FDA 510(k) record. The listed applicant is 3M Healthcare. It received FDA 510(k) clearance on 2016-08-23 under 510(k) number K153571. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cavilon Advanced High Endurance Skin Protectant?

Cavilon Advanced High Endurance Skin Protectant is a medical device that received FDA 510(k) clearance on 2016-08-23. The listed applicant is 3M Healthcare. The 510(k) number is K153571.

When did Cavilon Advanced High Endurance Skin Protectant receive FDA 510(k) clearance?

Cavilon Advanced High Endurance Skin Protectant received FDA 510(k) clearance on 2016-08-23, under 510(k) number K153571.

Who is the listed applicant for Cavilon Advanced High Endurance Skin Protectant?

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

What is the FDA product code for Cavilon Advanced High Endurance Skin Protectant?

The FDA product code for Cavilon Advanced High Endurance Skin Protectant is KMF.

其他以 3M Healthcare 為申請人之記錄

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K1931103M Attest 離子化過氧化氫三重指標化學指示標誌 1348/1348E K1913553M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask K1808743M 高性能外科口罩，3M 高性能外科口罩配面罩 K1804043M Clarity Ultra 自鍊結牙弓和粘合劑塗覆器具系統 K1711163M™ VFlex™ Health Care Particulate Respirator and Surgical Mask, Models 1804/1804S

相關器械（代碼：KMF）

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。

K241916撕裂修復液皮膚保護劑Optmed, Inc.K182733羅查生物防護矽膠薄膜Rochal Industries, LLC K171148Aleo BME液態傷口敷料Aleo Bme, Inc.K160684Atteris No-Sting Skin ProtectantRochal Industries, LLC

官方來源

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