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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis,retinal
Review Panel Ophthalmic
Product CodeNBF
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Contact Lenses and Retinal Devices Branch (CLRD)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible