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U.S. Department of Health and Human Services

Product Classification

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Device endoscope, ophthalmic
Regulation Description Endoscope and accessories.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Ophthalmic
Product CodeKYH
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 876.1500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons