美派斯膠柔軟矽膠密封膠
K 號：K152741 · 2016-01-22
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器材摘要
Mepiseal Soft Silicone Sealant is the device name listed in this FDA 510(k) record. The listed applicant is Molnlycke Health Care Us, LLC. It received FDA 510(k) clearance on 2016-01-22 under 510(k) number K152741. 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 Mepiseal Soft Silicone Sealant?
Mepiseal Soft Silicone Sealant is a medical device that received FDA 510(k) clearance on 2016-01-22. The listed applicant is Molnlycke Health Care Us, LLC. The 510(k) number is K152741.
When did Mepiseal Soft Silicone Sealant receive FDA 510(k) clearance?
Mepiseal Soft Silicone Sealant received FDA 510(k) clearance on 2016-01-22, under 510(k) number K152741.
Who is the listed applicant for Mepiseal Soft Silicone Sealant?
The FDA 510(k) record lists Molnlycke Health Care Us, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Mepiseal Soft Silicone Sealant?
The FDA product code for Mepiseal Soft Silicone Sealant is OMP.
相關臨床試驗
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其他以 Molnlycke Health Care Us, LLC 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：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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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