510(k) K152522

ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes by Ecolab, Inc. — Product Code LHC

K152522 is an FDA 510(k) premarket notification submitted by Ecolab, Inc. for the device "ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes". The FDA issued a decision of Substantially Equivalent on January 15, 2016. The device falls under product code LHC (Warmer, Irrigation Solution), a Class I device regulated under 21 CFR 890.5950. Ecolab, Inc. has at least 6 other 510(k) clearances on record.