510(k) K013689

RE-ENTRANT CHAMBER by Sun Nuclear Corp. — Product Code KPT

K013689 is an FDA 510(k) premarket notification submitted by Sun Nuclear Corp. for the device "RE-ENTRANT CHAMBER". The FDA issued a decision of Substantially Equivalent on July 2, 2002. The device falls under product code KPT (Calibrator, Dose, Radionuclide), a Class II device regulated under 21 CFR 892.1360. Sun Nuclear Corp. has at least 10 other 510(k) clearances on record.