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U.S. Department of Health and Human Services

Product Classification

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Device pump, infusion, ophthalmic
Regulation Description Infusion pump.
Regulation Medical Specialty General Hospital
Review Panel Ophthalmic
Product CodeMRH
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 880.5725
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review
Accredited Persons

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