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U.S. Department of Health and Human Services

Product Classification

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Device injector, capsular tension ring
Regulation Description Intraocular lens guide.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeNCE
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.4300
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review
Accredited Persons
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