510(k) K021916

HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001 by Harmac Medical Products, Inc. — Product Code FPA

K021916 is an FDA 510(k) premarket notification submitted by Harmac Medical Products, Inc. for the device "HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001". The FDA issued a decision of Substantially Equivalent on August 29, 2002. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Harmac Medical Products, Inc. has at least 7 other 510(k) clearances on record.