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U.S. Department of Health and Human Services

Product Classification

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Device device, antichoke, suction
Regulation Description Suction antichoke device.
Definition Call for pmas on 7/13/99 per 64 fr 18329 on 4/14/99.
Regulation Medical Specialty Ear Nose & Throat
Review Panel Ear Nose & Throat
Product CodeEWT
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Ear, Nose, and Throat Devices Branch (ENTB)
Submission Type PMA
Regulation Number 874.5350
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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