510(k) K023595

BURETTE-IN LINE (150 ML) by Tuta Healthcare Pty Limited — Product Code FPA

K023595 is an FDA 510(k) premarket notification submitted by Tuta Healthcare Pty Limited for the device "BURETTE-IN LINE (150 ML)". The FDA issued a decision of Substantially Equivalent on December 18, 2002. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Tuta Healthcare Pty Limited has at least 2 other 510(k) clearances on record.