510(k) K113021

TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT by CSA Medical, Inc. — Product Code GEH

K113021 is an FDA 510(k) premarket notification submitted by CSA Medical, Inc. for the device "TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT". The FDA issued a decision of Substantially Equivalent on Feb 7, 2012. 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.