510(k) K811916

OPERATING ROOM KIT by American Hospital Supply Corp. — Product Code FSM

K811916 is an FDA 510(k) premarket notification submitted by American Hospital Supply Corp. for the device "OPERATING ROOM KIT". The FDA issued a decision of Substantially Equivalent on October 14, 1981. The device falls under product code FSM (Tray, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. American Hospital Supply Corp. has at least 10 other 510(k) clearances on record.