510(k) K050384

KAPP BARI-RING, MODEL KS-BR-2005 by Kapp Surgical Instrument, Inc. — Product Code NEU

K050384 is an FDA 510(k) premarket notification submitted by Kapp Surgical Instrument, Inc. for the device "KAPP BARI-RING, MODEL KS-BR-2005". The FDA issued a decision of Substantially Equivalent on January 13, 2006. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Kapp Surgical Instrument, Inc. has at least 8 other 510(k) clearances on record.