510(k) K991319

RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS by Orfit Industries — Product Code IYE

K991319 is an FDA 510(k) premarket notification submitted by Orfit Industries for the device "RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS". The FDA issued a decision of Substantially Equivalent on September 21, 1999. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Orfit Industries has at least 10 other 510(k) clearances on record.