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)
"HOLTER-HAUSNER" H-H CATHETER-RESERVOIR "HOLTER-HAUSNER" H-H CATHETER-RESERVOIR 衛 部 醫器 製 壹 字 第 008527 號 衛 部 醫器 製 壹 字 第 008562 號 CA38 佳貝士印模粉 齒模粉比例 AcuStar “真安欣”機械式輪椅 (未滅菌) "CHIA CHERNE" Nasal oxygen cannula (Non-Sterile)
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
HOLTER-HAUSNER 相關藥物@ | 合法醫療器材資訊網
腦室導管附貯水閥"HOLTER-HAUSNER" H | 合法醫療器材資訊網
腦室導管附貯水閥 | 合法醫療器材資訊網
相關資訊整理
【腦室導管附貯水閥】許可證字號:衛署醫器輸字第005122號
器材品名:腦室導管附貯水閥許可證字號:衛署醫器輸字第005122號註銷狀態:已註銷註銷日期:1999/10/06註銷理由:未展延而逾期者;...