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U.S. Department of Health and Human Services

Product Classification

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Device system, dialysate delivery, single patient
Regulation Description Hemodialysis system and accessories.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeFKP
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Renal Devices Branch (RNDB)
Submission Type 510(k)
Regulation Number 876.5820
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Documents
  • Regulatory Status of Disinfectants Used to Process Dialysate Delivery Systems and Water Purification Systems for Hemodialysis; Guidance for Industry and FDA
  • Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems; Final
Third Party Review Not Third Party Eligible
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