510(k) K994197

DISENTRONIC PENFINE INJECTION PEN NEEDLE by Disetronic Medical Systems — Product Code FMI

K994197 is an FDA 510(k) premarket notification submitted by Disetronic Medical Systems for the device "DISENTRONIC PENFINE INJECTION PEN NEEDLE". The FDA issued a decision of Substantially Equivalent on December 29, 1999. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Disetronic Medical Systems has at least 10 other 510(k) clearances on record.