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U.S. Department of Health and Human Services

Product Classification

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Device dialysate concentrate for hemodialysis (liquid or powder)
Regulation Description Hemodialysis system and accessories.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeKPO
Premarket Review Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors (OHT3)
Gastroenterology, Renal, Endoscopy, Transplant and Obesity Devices (DHT3A)
Submission Type 510(k)
Regulation Number 876.5820
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible
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