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U.S. Department of Health and Human Services

Product Classification

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Device ocular peg
Regulation Description Eye sphere implant.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeMQU
Premarket Review Opthalmic, Anaesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.3320
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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