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U.S. Department of Health and Human Services

Product Classification

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Device implant, eye valve
Regulation Description Aqueous shunt.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeKYF
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Intraocular and Corneal Implants Devices Branch (ICIB)
Submission Type 510(k)
Regulation Number 886.3920
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Aqueous Shunts - 510(k) Submissions; Final
Third Party Review Not Third Party Eligible
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