510(k) K982624

MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 by Med-Tec,Inc. — Product Code IYE

K982624 is an FDA 510(k) premarket notification submitted by Med-Tec,Inc. for the device "MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242". The FDA issued a decision of Substantially Equivalent on October 26, 1998. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Med-Tec,Inc. has at least 7 other 510(k) clearances on record.