510(k) K962802

SAFE MATE I.V. FLUID DELIVERY SETS by Biological & Environmental Control Laboratories — Product Code FPA

K962802 is an FDA 510(k) premarket notification submitted by Biological & Environmental Control Laboratories for the device "SAFE MATE I.V. FLUID DELIVERY SETS". The FDA issued a decision of Substantially Equivalent on August 28, 1996. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Biological & Environmental Control Laboratories has at least 10 other 510(k) clearances on record.