Classification Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Product Code: GEI
Device Class: 2
Regulation Number: 878.4400
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: ThermiGen, LLC
Registered Establishment Number: 3010266937
Premarket Submission Number: K130689
Owner/Operator: Thermi
Owner/Operator Number: 10044489
Establishment Operations: Manufacturer; Specification Developer