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U.S. Department of Health and Human Services

Product Classification

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Device plug, scleral
Regulation Description Scleral plug.
Definition Intended to provide temporary closure of a scleral incision during an ophthalmic procedure.
Target Area Eye
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeLXP
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.4155
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 Not Third Party Eligible
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