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Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled Misbranding by reference to premarket notification 21 CFR Part 807. Indications for Use Statement 510k Number K142561 510 k Number if known K142561 Device Name LM-9300 ELMA The Lite-Med LM-9300 ELMA Lithotripter is indicated for fragmentation of kidney stones such as renal calyx stones and renal pelvic stones and for upper middle and lower ureteral stones by extracorporeal shock wave...
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Lite-Med Inc. is a medical equipment manufacturing company.
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