510(k) K023917

WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR by Kawasumi Laboratories, Inc. — Product Code FPA

K023917 is an FDA 510(k) premarket notification submitted by Kawasumi Laboratories, Inc. for the device "WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR". The FDA issued a decision of Substantially Equivalent on February 26, 2003. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Kawasumi Laboratories, Inc. has at least 10 other 510(k) clearances on record.