510(k) K973152

GALLINI ABS DEVICE by Gallini U.S., LLC — Product Code KNW

K973152 is an FDA 510(k) premarket notification submitted by Gallini U.S., LLC for the device "GALLINI ABS DEVICE". The FDA issued a decision of Substantially Equivalent on Jan 9, 1998. 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.