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U.S. Department of Health and Human Services

Product Classification
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Device lens, contact, polymethylmethacrylate, diagnostic
Regulation Description Polymethylmethacrylate (PMMA) diagnostic contact lens.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeHJK
Submission Type 510(k)
Regulation Number 886.1385
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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