PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET

PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET is an FDA 510(k)-cleared medical device (K950178) manufactured by Pharma-Plast Intl. A/S. This device is classified under the Orthopedic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 16, 1995. Regulation: 8.