510(k) K974387

PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE by Microwave Medical Systems, Inc. — Product Code KDJ

K974387 is an FDA 510(k) premarket notification submitted by Microwave Medical Systems, Inc. for the device "PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE". The FDA issued a decision of Substantially Equivalent on September 1, 1999. The device falls under product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable), a Class II device regulated under 21 CFR 876.5630. Microwave Medical Systems, Inc. has at least 4 other 510(k) clearances on record.