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U.S. Department of Health and Human Services

Product Classification

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Device endoilluminator
Regulation Description Endoscope and accessories.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Ophthalmic
Product CodeMPA
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Diagnostic and Surgical Devices Branch (DSDB)
Submission Type 510(k)
Regulation Number 876.1500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review
Accredited Persons

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