510(k) K892428

COMBI-CAP by The Medi-Dose Group — Product Code FMF

K892428 is an FDA 510(k) premarket notification submitted by The Medi-Dose Group for the device "COMBI-CAP". The FDA issued a decision of Substantially Equivalent on Jul 14, 1989. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. The Medi-Dose Group has at least 9 other 510(k) clearances on record.