510(k) K945617

PHARMA-PLAST PURELINE(TM) BASIC(TM) AND PURELINE(TM) CONTACT(TM) SUBCUTANEOUS INFUSION SETS by Pharma-Plast Intl. A/S — Product Code FPA

K945617 is an FDA 510(k) premarket notification submitted by Pharma-Plast Intl. A/S for the device "PHARMA-PLAST PURELINE(TM) BASIC(TM) AND PURELINE(TM) CONTACT(TM) SUBCUTANEOUS INFUSION SETS". The FDA issued a decision of Substantially Equivalent on February 13, 1995. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Pharma-Plast Intl. A/S has at least 1 other 510(k) clearance on record.