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U.S. Department of Health and Human Services

Product Classification

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Device lens, contact (other material) - daily
Regulation Description Rigid gas permeable contact lens.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeHQD
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 886.5916
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review
Accredited Persons

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