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U.S. Department of Health and Human Services

Product Classification

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Device elastomer, silicone block
Regulation Description Ear, nose, and throat synthetic polymer material.
Regulation Medical Specialty Ear Nose & Throat
Review Panel General & Plastic Surgery
Product CodeMIB
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type 510(k)
Regulation Number 874.3620
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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