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U.S. Department of Health and Human Services

Product Classification

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Device unit, beta, radiation, ophthalmic
Regulation Description Ophthalmic beta radiation source.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeHRL
Premarket Review Opthalmic, Anaesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.5100
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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