510(k) K880416

WCCS 800 WALLACH CARDIAC CRYOSURGICAL SYSTEM by Wallach Surgical Devices, Inc. — Product Code GEH

K880416 is an FDA 510(k) premarket notification submitted by Wallach Surgical Devices, Inc. for the device "WCCS 800 WALLACH CARDIAC CRYOSURGICAL SYSTEM". The FDA issued a decision of Substantially Equivalent on September 26, 1988. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Wallach Surgical Devices, Inc. has at least 10 other 510(k) clearances on record.