510(k) K811390

CCS100 CRYOSURGICAL SYSTEM by Frigitronics of Connecticut, Inc. — Product Code GEH

K811390 is an FDA 510(k) premarket notification submitted by Frigitronics of Connecticut, Inc. for the device "CCS100 CRYOSURGICAL SYSTEM". The FDA issued a decision of Substantially Equivalent on June 16, 1981. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Frigitronics of Connecticut, Inc. has at least 8 other 510(k) clearances on record.