510(k) K901079

SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER by L H M Ent., Inc. — Product Code BTO

K901079 is an FDA 510(k) premarket notification submitted by L H M Ent., Inc. for the device "SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER". The FDA issued a decision of Substantially Equivalent on May 18, 1990. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. L H M Ent., Inc. has at least 5 other 510(k) clearances on record.