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U.S. Department of Health and Human Services

Product Classification
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Device system, dialysate delivery, sorbent regenerated
Regulation Description Sorbent regenerated dialysate delivery system for hemodialysis.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeFKT
Submission Type 510(k)
Regulation Number 876.5600
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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