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U.S. Department of Health and Human Services

Product Classification

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Device laser, ent microsurgical carbon-dioxide
Regulation Description Ear, nose, and throat microsurgical carbon dioxide laser.
Regulation Medical Specialty Ear Nose & Throat
Review Panel Ear Nose & Throat
Product CodeEWG
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Ear, Nose, and Throat Devices Branch (ENTB)
Submission Type 510(k)
Regulation Number 874.4500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review
Accredited Persons

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