510(k) K823412

ARM BOARD W/I.V COVERING by Sage Products, Inc. — Product Code BTX

K823412 is an FDA 510(k) premarket notification submitted by Sage Products, Inc. for the device "ARM BOARD W/I.V COVERING". The FDA issued a decision of Substantially Equivalent on December 15, 1982. The device falls under product code BTX (Board, Arm (With Cover), Sterile), a Class I device regulated under 21 CFR 878.3910. Sage Products, Inc. has at least 10 other 510(k) clearances on record.