510(k) K990645

GALLINI ATRA-CUT NEEDLE by Gallini U.S., LLC — Product Code KNW

K990645 is an FDA 510(k) premarket notification submitted by Gallini U.S., LLC for the device "GALLINI ATRA-CUT NEEDLE". The FDA issued a decision of Substantially Equivalent on May 19, 1999. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Gallini U.S., LLC has 9 other 510(k) clearances on record.