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U.S. Department of Health and Human Services

Product Classification
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Device keratoprosthesis, permanent implant
Regulation Description Keratoprosthesis.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeHQM
Premarket Review Ophthalmic Devices (DHT1A)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.3400
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
Guidance Document
Third Party Review Not Third Party Eligible
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