510(k) K945591

APPLIED MEDICAL OPTICAL VALVULOTOME by Applied Medical Resources — Product Code LYK

K945591 is an FDA 510(k) premarket notification submitted by Applied Medical Resources for the device "APPLIED MEDICAL OPTICAL VALVULOTOME". The FDA issued a decision of Substantially Equivalent on February 10, 1995. The device falls under product code LYK (Angioscope), a Class II device regulated under 21 CFR 876.1500. Applied Medical Resources has at least 10 other 510(k) clearances on record.