510(k) K904658

AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY ASPIR. DEV by Leigh Med Tech, Inc. — Product Code KNW

K904658 is an FDA 510(k) premarket notification submitted by Leigh Med Tech, Inc. for the device "AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY ASPIR. DEV". The FDA issued a decision of Substantially Equivalent on November 20, 1990. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Leigh Med Tech, Inc. has at least 1 other 510(k) clearance on record.