510(k) K060141

DAI-R by Shl Medical, USA — Product Code KZH

K060141 is an FDA 510(k) premarket notification submitted by Shl Medical, USA for the device "DAI-R". The FDA issued a decision of Substantially Equivalent on June 12, 2006. The device falls under product code KZH (Introducer, Syringe Needle), a Class II device regulated under 21 CFR 880.6920. Shl Medical, USA has at least 1 other 510(k) clearance on record.