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U.S. Department of Health and Human Services

Product Classification

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Device unit, beta, radiation, ophthalmic
Regulation Description Ophthalmic beta radiation source.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeHRL
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 886.5100
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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