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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 886 - Ophthalmic Devices |
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Subpart B - Diagnostic Devices |
§ 886.1385 - Polymethylmethacrylate (PMMA) diagnostic contact lens.
Latest version.
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§ 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.
(a) Identification. A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.
(b) Classification. Class II.