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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 Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Intraocular and Corneal Implants Devices Branch (ICIB)
Submission Type PMA
Regulation Number 886.4270
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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