510(k) K032156

ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT by Wfr/Aquaplast Corp. — Product Code IYE

K032156 is an FDA 510(k) premarket notification submitted by Wfr/Aquaplast Corp. for the device "ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT". The FDA issued a decision of Substantially Equivalent on September 2, 2003. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Wfr/Aquaplast Corp. has at least 7 other 510(k) clearances on record.