PQN — Carbon Dioxide Gas Controlled Tissue Expander Class II

FDA Device Classification

FDA product code PQN covers "Carbon Dioxide Gas Controlled Tissue Expander", a Class II medical device regulated under 21 CFR 878.3510. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 3 recent 510(k) clearances have been granted under this product code.