510(k) K061133

SIMEX SUCTION PUMP, MODELS AC20, AC20K, AC30, DC20, DC30 AND DC30S by Novaspine, LLC — Product Code BTA

K061133 is an FDA 510(k) premarket notification submitted by Novaspine, LLC for the device "SIMEX SUCTION PUMP, MODELS AC20, AC20K, AC30, DC20, DC30 AND DC30S". The FDA issued a decision of Substantially Equivalent on July 11, 2006. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Novaspine, LLC has at least 2 other 510(k) clearances on record.