510(k) K083284

PIEZOSURGERY MEDICAL by Piezosurgery S.R.L. — Product Code JDX

K083284 is an FDA 510(k) premarket notification submitted by Piezosurgery S.R.L. for the device "PIEZOSURGERY MEDICAL". The FDA issued a decision of Substantially Equivalent on April 8, 2009. The device falls under product code JDX (Instrument, Surgical, Sonic And Accessory/Attachment), a Class II device regulated under 21 CFR 888.4580. Piezosurgery S.R.L. has at least 3 other 510(k) clearances on record.