510(k) K895290

CHEMO-SPIKE RECONSTITUTION DEVICE by The Medi-Dose Group — Product Code FPA

K895290 is an FDA 510(k) premarket notification submitted by The Medi-Dose Group for the device "CHEMO-SPIKE RECONSTITUTION DEVICE". The FDA issued a decision of Substantially Equivalent on Dec 27, 1989. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. The Medi-Dose Group has at least 9 other 510(k) clearances on record.