About This 510(k) Submission
K990349 is an FDA 510(k) clearance for the WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST, a Catheter, Assisted Reproduction (Class II — Special Controls, product code MQF), submitted by CooperSurgical, Inc. (Shelton, US). The FDA issued a Cleared decision on July 26, 1999, 171 days after receiving the submission on February 5, 1999. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6110.