510(k) K905007

STANDARD BREAST BOARDS; DELUXE BREAST BOARD by Bionix Development Corp. — Product Code IYE

K905007 is an FDA 510(k) premarket notification submitted by Bionix Development Corp. for the device "STANDARD BREAST BOARDS; DELUXE BREAST BOARD". The FDA issued a decision of Substantially Equivalent on February 12, 1991. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Bionix Development Corp. has at least 10 other 510(k) clearances on record.