VAGINAL CHAMBER PELLETHANE-MEDICAL GRADE 2363

VAGINAL CHAMBER PELLETHANE-MEDICAL GRADE 2363 is an FDA 510(k)-cleared medical device (K861858) manufactured by Peritone Research, 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 July 30, 1986. Regulation: 8.