510(k) Premarket Notification | 合法醫療器材資訊網
Results1-10of49—ProductCode:GEXApplicant:LASERSCOPEDecisionDateTo:05/09/2021...orionseriessurgicallasersystem(slseriesq-switchednd:yag ...
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)
ORION SURGICAL LASER SYSTEM "LASERSCOPE" ORION SURGICAL LASER SYSTEM "LASERSCOPE" “紐可適”橫膈節律系統 南開 nidek氧氣製造機代理商 “MEDA” Ultrasonic A/B Scanner for Ophthalmology "崔普" 彈性鬆緊護具 (未滅菌) western blot壓片 西方墨點法elisa western blot問題
510(k) Premarket Notification | 合法醫療器材資訊網
Device Classification Name, powered laser surgical instrument22. 510(k) Number, K964818. Device Name, ORION SERIES SURGICAL LASER SYSTEM ... Read More
510(k) Premarket Notification | 合法醫療器材資訊網
Device Classification Name, powered laser surgical instrument22. 510(k) Number, K990718. Device Name, ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION). Applicant. LASERSCOPE. Read More
510(k) Premarket Notification | 合法醫療器材資訊網
Results 1 - 10 of 49 — ProductCode: GEX Applicant: LASERSCOPE Decision Date To: 05/09/2021 ... orion series surgical laser system (sl seriesq-switched nd:yag ... Read More
Laserscope Greenlight PV Surgical Urology Laser 0010 | 合法醫療器材資訊網
LASERSCOPE GREENLIGHT HPS 0010-0070 LASER ! (265159). $550.00. + $495.00 shipping · ORION STAR PULSE Laserscope KTP/532 Surgical Laser ... Read More
ORION STAR PULSE Laserscope KTP532 Surgical Laser ... | 合法醫療器材資訊網
Item is used. We are unable to test at our facility. Working condition is unknown. Unit has stains, scuffs, scratches and writing. See photos. "The sale of this item ... Read More
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