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U.S. Department of Health and Human Services

Product Classification

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Device tube, tympanostomy with semi-permeable membrane
Regulation Description Tympanostomy tube with semipermeable membrane.
Regulation Medical Specialty Ear Nose & Throat
Review Panel Ear Nose & Throat
Product CodeKQL
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 874.3930
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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