SOFTSEAL HSG CATHETER

SOFTSEAL HSG CATHETER is an FDA 510(k)-cleared medical device (K040238) manufactured by Modern Medical Equipment Mfg., Ltd.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 21, 2004. Regulation: 8.