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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
Premarket Review Opthalmic, Anaesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.1385
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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