AMER. PHARMASEAL SILICONIZED LATEX

AMER. PHARMASEAL SILICONIZED LATEX is an FDA 510(k)-cleared medical device (K841544) manufactured by American Pharmaseal Div. Ahsc. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 8, 1984. Regulation: 8.