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U.S. Department of Health and Human Services

Product Classification

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Device tube, shunt, endolymphatic with valve
Regulation Description Endolymphatic shunt tube with valve.
Regulation Medical Specialty Ear Nose & Throat
Review Panel Ear Nose & Throat
Product CodeKLZ
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 874.3850
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Class II Special Controls Guidance Document: Endolymphatic Shunt Tube with Valve; Guidance for Industry and FDA
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible