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U.S. Department of Health and Human Services

Product Classification

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Device kit, repair, catheter, hemodialysis
Regulation Description Blood access device and accessories.
Definition Hemodialysis tray.
Physical State Hemodialysis Tray
Technical Method Hemodialysis Tray
Target Area Hemodialysis Tray
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeNFK
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 876.5540
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Convenience Kits Interim Regulatory Guidance
Third Party Review Not Third Party Eligible
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