510(k) K003076

MITEK CUFFTACK by Mitek Products — Product Code MAI

K003076 is an FDA 510(k) premarket notification submitted by Mitek Products for the device "MITEK CUFFTACK". The FDA issued a decision of Substantially Equivalent on October 27, 2000. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Mitek Products has at least 10 other 510(k) clearances on record.