510(k) K971500

ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER by Biological & Environmental Control Laboratories — Product Code FPA

K971500 is an FDA 510(k) premarket notification submitted by Biological & Environmental Control Laboratories for the device "ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER". The FDA issued a decision of Substantially Equivalent on August 18, 1997. 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.