510(k) K891282

MIC-100 WITH CRYOPROBES by Frigitronics of Connecticut, Inc. — Product Code GEH

K891282 is an FDA 510(k) premarket notification submitted by Frigitronics of Connecticut, Inc. for the device "MIC-100 WITH CRYOPROBES". The FDA issued a decision of Substantially Equivalent on June 15, 1989. 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.