510(k) K982029

SHARPS COLLECTION CONTAINER - SAF-T-SHELL by American Medical Mfg., Inc. — Product Code FMI

K982029 is an FDA 510(k) premarket notification submitted by American Medical Mfg., Inc. for the device "SHARPS COLLECTION CONTAINER - SAF-T-SHELL". The FDA issued a decision of Substantially Equivalent on April 6, 1999. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. American Medical Mfg., Inc. has at least 5 other 510(k) clearances on record.