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U.S. Department of Health and Human Services

Product Classification

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Device knife, ophthalmic, reprocessed
Regulation Description Manual ophthalmic surgical instrument.
Definition Used for cutting soft tissue in or around the eye.Surgical knife same as product code hnn, except this one is reprocessed.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeNLA
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 886.4350
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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