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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: CODMAN MALIS Mirror Finish Bipolar Forceps; CODMAN Mirror Finish Bipolar Forceps; CODMAN RHOTON Mirror Finish Bipolar Forceps; CODMAN Spetzler Mirror Finish Bipolar Forceps; CODMAN® YASARGIL Mirror Finish Bipolar Forceps
Classification Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Product Code: GEI
Device Class: 2
Regulation Number: 878.4400
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: Integra LifeSciences Production Corporation
Registered Establishment Number: 3014334038
Premarket Submission Number: K963499
Owner/Operator: Integra LifeSciences Corporation
Owner/Operator Number: 9004007
Establishment Operations: Manufacturer; Specification Developer
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