EMPTY SOLUTION TRANSFER CONTAINER 1000

About This 510(k) Submission

K843523 is an FDA 510(k) clearance for the EMPTY SOLUTION TRANSFER CONTAINER 1000, a Container, I.v. (Class II — Special Controls, product code KPE), submitted by Polymer Technology Corp. (Whitwater, US). The FDA issued a Cleared decision on October 16, 1984, 39 days after receiving the submission on September 7, 1984. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5025.