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U.S. Department of Health and Human Services

Product Classification

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Device colonic irrigation system, general well being
Regulation Description Colonic irrigation system.
Definition Call for pmas on 12/26/96 per 61 fr 50707 on 9/27/96 - colon cleansing for routine general well being.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeNUB
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Gastroenterology Devices Branch (GEDB)
Submission Type PMA
Regulation Number 876.5220
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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