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U.S. Department of Health and Human Services

Product Classification
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Device wrap, implant, orbital
Regulation Description Eye sphere implant.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeMTZ
Premarket Review Office of Ophthalmic, Anesthesia, 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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