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U.S. Department of Health and Human Services

Product Classification

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Device gases used within eye to place pressure on detached retina
Regulation Description Intraocular gas.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeLPO
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type PMA
Regulation Number 886.4270
Device Class 3
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 Not Third Party Eligible
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