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U.S. Department of Health and Human Services

Product Classification

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Device implant, absorbable, (scleral buckling methods)
Regulation Description Absorbable implant (scleral buckling method).
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeHQJ
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Intraocular and Corneal Implants Devices Branch (ICIB)
Submission Type 510(k)
Regulation Number 886.3300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible