510(k) K854877

ACU-SYRINGE W/WO NEEDLES by Acuderm, Inc. — Product Code FMF

K854877 is an FDA 510(k) premarket notification submitted by Acuderm, Inc. for the device "ACU-SYRINGE W/WO NEEDLES". The FDA issued a decision of Substantially Equivalent on February 19, 1986. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Acuderm, Inc. has at least 10 other 510(k) clearances on record.