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U.S. Department of Health and Human Services

Product Classification

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Device electrode, corneal
Regulation Description Corneal electrode.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeHLZ
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Diagnostic and Surgical Devices Branch (DSDB)
Submission Type 510(k)
Regulation Number 886.1220
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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