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U.S. Department of Health and Human Services

Product Classification

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Device oral removable retainer for weight management
Definition A removable oral device used during meals to limit food intake.
Physical State Stainless steel wire, electrical sensor and palatal mold (polymer)
Technical Method Intraorally limits bite size
Target Area Mouth
Review Panel Gastroenterology/Urology
Product CodeONY
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Gastroenterology Devices Branch (GEDB)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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