B-D E ML PEN

About This 510(k) Submission

K980755 is an FDA 510(k) clearance for the B-D E ML PEN, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on April 2, 1998, 36 days after receiving the submission on February 25, 1998. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.