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U.S. Department of Health and Human Services

Product Classification

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Device masker, tinnitus
Regulation Description Tinnitus masker.
Regulation Medical Specialty Ear Nose & Throat
Review Panel Ear Nose & Throat
Product CodeKLW
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 874.3400
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Tinnitus Masker Devices - Class II Special Controls Guidance Document - Draft Guidance for Industry and FDA Staff
Third Party Review
Accredited Persons

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