510(k) K971053

ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS by International Medical Products, Inc. — Product Code KPO

K971053 is an FDA 510(k) premarket notification submitted by International Medical Products, Inc. for the device "ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS". The FDA issued a decision of Substantially Equivalent on June 16, 1997. The device falls under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)), a Class II device regulated under 21 CFR 876.5820. International Medical Products, Inc. has at least 9 other 510(k) clearances on record.