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U.S. Department of Health and Human Services

Product Classification

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Device keratoprosthesis, temporary implant, surgical use
Regulation Description Keratoprosthesis.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeMLP
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 886.3400
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance on 510(k) Submissions for Keratoprostheses, Final
Third Party Review
Accredited Persons

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