510(k) K954041

G.R.E.E.N. DISPOSAL CONTAINER (NOTE: G.R.E.E.N. IS AN ACRONYM FOR GLAXO RETRIEVAL EFFORT FOR EXPENDED NEEDLES) by Glaxo, Inc. — Product Code FMI

K954041 is an FDA 510(k) premarket notification submitted by Glaxo, Inc. for the device "G.R.E.E.N. DISPOSAL CONTAINER (NOTE: G.R.E.E.N. IS AN ACRONYM FOR GLAXO RETRIEVAL EFFORT FOR EXPENDED NEEDLES)". The FDA issued a decision of Substantially Equivalent on October 16, 1995. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Glaxo, Inc. has at least 3 other 510(k) clearances on record.