510(k) K990083

CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER by Sims Deltec, Inc. — Product Code FPA

K990083 is an FDA 510(k) premarket notification submitted by Sims Deltec, Inc. for the device "CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER". The FDA issued a decision of Substantially Equivalent on February 12, 1999. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Sims Deltec, Inc. has at least 10 other 510(k) clearances on record.