CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C

CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C is an FDA 510(k)-cleared medical device (K052798) manufactured by Isovac Products, LLC. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 5, 2006. Regulation: 8.