510(k) K093781

MODIFIED: NEWDEAL HALLU PLATES by Newdeal Sas — Product Code HRS

K093781 is an FDA 510(k) premarket notification submitted by Newdeal Sas for the device "MODIFIED: NEWDEAL HALLU PLATES". The FDA issued a decision of Substantially Equivalent on January 22, 2010. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Newdeal Sas has at least 9 other 510(k) clearances on record.