510(k) K052622

MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT by Macan Engineering Co. — Product Code EKZ

K052622 is an FDA 510(k) premarket notification submitted by Macan Engineering Co. for the device "MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT". The FDA issued a decision of Substantially Equivalent on December 9, 2005. The device falls under product code EKZ (Unit, Electrosurgical, And Accessories, Dental), a Class II device regulated under 21 CFR 872.4920. Macan Engineering Co. has at least 1 other 510(k) clearance on record.