510(k) K912054

LABOR DELIVERY TRAY by Medical Device Inspection Co., Inc. — Product Code HFW

K912054 is an FDA 510(k) premarket notification submitted by Medical Device Inspection Co., Inc. for the device "LABOR DELIVERY TRAY". The FDA issued a decision of Substantially Equivalent (kit) on January 21, 1992. The device falls under product code HFW (Clamp, Umbilical), a Class II device regulated under 21 CFR 884.4530. Medical Device Inspection Co., Inc. has at least 10 other 510(k) clearances on record.