510(k) K060260

MICROPOWER HAND PIECE HIGH SPEED DRILL by Linvatec Corp. — Product Code HBC

K060260 is an FDA 510(k) premarket notification submitted by Linvatec Corp. for the device "MICROPOWER HAND PIECE HIGH SPEED DRILL". The FDA issued a decision of Substantially Equivalent on April 10, 2006. The device falls under product code HBC (Motor, Drill, Electric), a Class II device regulated under 21 CFR 882.4360. Linvatec Corp. has at least 10 other 510(k) clearances on record.