50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB

About This 510(k) Submission

K070264 is an FDA 510(k) clearance for the 50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Terumo Europe N.V. (Leuven, BE). The FDA issued a Cleared decision on May 29, 2007, 120 days after receiving the submission on January 29, 2007. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.