About This 510(k) Submission
K983897 is an FDA 510(k) clearance for the CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G, a Set, Anesthesia, Paracervical (Class II — Special Controls, product code HEE), submitted by Ri Mos. S.R.L. (Concord, US). The FDA issued a Cleared decision on February 1, 1999, 90 days after receiving the submission on November 3, 1998. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5100.