510(k) K973911

2 GALLON ALTERNATE CARE SHARPS CONTAINER by Sage Products, Inc. — Product Code FMI

K973911 is an FDA 510(k) premarket notification submitted by Sage Products, Inc. for the device "2 GALLON ALTERNATE CARE SHARPS CONTAINER". The FDA issued a decision of Substantially Equivalent on October 29, 1997. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Sage Products, Inc. has at least 10 other 510(k) clearances on record.