510(k) K983818

MITEK FASTIN RC ANCHOR by Mitek Products — Product Code MBI

K983818 is an FDA 510(k) premarket notification submitted by Mitek Products for the device "MITEK FASTIN RC ANCHOR". The FDA issued a decision of Substantially Equivalent on November 23, 1998. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Mitek Products has at least 10 other 510(k) clearances on record.