K990083 - CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER
(FDA 510(k) Clearance)

K990083 is an FDA 510(k) clearance for the CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Sims Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on February 12, 1999, 32 days after receiving the submission on January 11, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.