510(k) K082908

NOVAGUARD, MODEL 3611001 by West Pharmaceutical Services, Inc. — Product Code FMI

K082908 is an FDA 510(k) premarket notification submitted by West Pharmaceutical Services, Inc. for the device "NOVAGUARD, MODEL 3611001". The FDA issued a decision of Substantially Equivalent on April 24, 2009. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. West Pharmaceutical Services, Inc. has at least 6 other 510(k) clearances on record.