510(k) K993435

MANUAL BONE MARROW BIOPSY DEVICE by Promex, Inc. — Product Code KNW

K993435 is an FDA 510(k) premarket notification submitted by Promex, Inc. for the device "MANUAL BONE MARROW BIOPSY DEVICE". The FDA issued a decision of Substantially Equivalent on December 6, 1999. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Promex, Inc. has at least 10 other 510(k) clearances on record.