510(k) K130995

NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY by Nuance Medical, LLC — Product Code GEH

K130995 is an FDA 510(k) premarket notification submitted by Nuance Medical, LLC for the device "NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY". The FDA issued a decision of Substantially Equivalent on June 14, 2013. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Nuance Medical, LLC has at least 5 other 510(k) clearances on record.