510(k) K810402

ACE COLD BANDAGE by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code IME

K810402 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "ACE COLD BANDAGE". The FDA issued a decision of Substantially Equivalent on March 4, 1981. The device falls under product code IME (Pack, Hot Or Cold, Reusable), a Class I device regulated under 21 CFR 890.5700. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.