510(k) K093608

GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H by Gambro Renal Products, Inc. — Product Code FIP

K093608 is an FDA 510(k) premarket notification submitted by Gambro Renal Products, Inc. for the device "GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H". The FDA issued a decision of Substantially Equivalent on July 29, 2010. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Gambro Renal Products, Inc. has at least 10 other 510(k) clearances on record.