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U.S. Department of Health and Human Services

Product Classification

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Device esophageal dilator with balloon and electrode sensors
Regulation Description Gastrointestinal tube and accessories.
Definition To dilate esophageal strictures with a dilating balloon and electrode sensors.
Physical State balloon with electrode sensors and software
Technical Method balloon with electrode sensors
Target Area esophagus
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodePIE
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Gastroenterology Devices Branch (GEDB)
Submission Type 510(k)
Regulation Number 876.5980
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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