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.
Learn more...[1]
References Learn more... (www.fda.gov)
"WALTER LORENZ" TITANIUM MESH "WALTER LORENZ" TITANIUM MESH Varian Eclipse Varian cryo vitros 4600 user manual vitros 250 user manual pdf EVD indication EVD medical Medtronic neurovascular Gamma 滅菌 公
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
相關資訊整理
【內植鈦質網】許可證字號:衛署醫器輸字第001315號
器材品名:內植鈦質網許可證字號:衛署醫器輸字第001315號註銷狀態:已註銷註銷日期:1986/08/29註銷理由:未展延而逾期者有效日...