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U.S. Department of Health and Human Services

Product Classification

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Device expander, tissue, orbital
Regulation Description Eye sphere implant.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeNFM
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 886.3320
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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