510(k) K965208

POLYFIN EXTENSION SET, MODELS 126 AND 128 by Medtronic Minimed — Product Code FPK

K965208 is an FDA 510(k) premarket notification submitted by Medtronic Minimed for the device "POLYFIN EXTENSION SET, MODELS 126 AND 128". The FDA issued a decision of Substantially Equivalent on February 26, 1997. The device falls under product code FPK (Tubing, Fluid Delivery), a Class II device regulated under 21 CFR 880.5440. Medtronic Minimed has at least 10 other 510(k) clearances on record.