510(k) K072651

CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM by CSA Medical, Inc. — Product Code GEH

K072651 is an FDA 510(k) premarket notification submitted by CSA Medical, Inc. for the device "CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM". The FDA issued a decision of Substantially Equivalent on December 7, 2007. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. CSA Medical, Inc. has at least 10 other 510(k) clearances on record.