ORTHO ALL-FLEX DIAPHRAGM

ORTHO ALL-FLEX DIAPHRAGM is an FDA 510(k)-cleared medical device (K080040) manufactured by Johnson & Johnson Produtos Profissionais Ltda.. 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 August 24, 2008. Regulation: 8.