510(k) Premarket Notification | 合法醫療器材資訊網
A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.
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References Learn more... (www.fda.gov)
"WALTER LORENZ" TITANIUM MESH "WALTER LORENZ" TITANIUM MESH “Medi”Truncal Orthosis(Non-Sterile) 博士倫日拋 茂傑國際股份有限公司股價 茂捷有限公司 茂杰貿易有限公司 cmv igg architect cmv igg 250 au/ml abbott cmv package insert
510(k) Premarket Notification | 合法醫療器材資訊網
510(k) Premarket Notification | 合法醫療器材資訊網
510(k) Premarket Notification | 合法醫療器材資訊網
510(k) Premarket Notification | 合法醫療器材資訊網
Lorenz® Plating System Neuro | 合法醫療器材資訊網
WALTER LORENZ SURGICAL INSTRUMENTS INC. 相關藥物 | 合法醫療器材資訊網
內植鈦質網 | 合法醫療器材資訊網
內植鈦質網· WALTER LORENZ TITANIUM MESH · 明惠貿易有限公司 | 合法醫療器材資訊網
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