510(k) K061933

HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER by Hager Worldwide, Inc. — Product Code FMI

K061933 is an FDA 510(k) premarket notification submitted by Hager Worldwide, Inc. for the device "HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER". The FDA issued a decision of Substantially Equivalent on November 16, 2006. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Hager Worldwide, Inc. has at least 2 other 510(k) clearances on record.