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U.S. Department of Health and Human Services

Product Classification

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Device system, ablation, microwave and accessories
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeNEY
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch Two - Surgical (GSDB2)
Submission Type 510(k)
Regulation Number 878.4400
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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