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)
"HITACHI" CAPACITOR DISCHARGE TYPE MOBILE X-RAY UNIT "HITACHI" CAPACITOR DISCHARGE TYPE MOBILE X-RAY UNIT 美商登士派薪資 IMMULITE Siemens Healthineers Siemens chemistry analyzers 積水普優歐鹼性磷酸酶測定試劑 "Shaanxi Xingmao" Manual surgical instrument for general use (Non-Sterile) esaote mylab 30 gold price 科協儀器股份有限公司
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