{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Richmond Hill, Ontario",
      "advisory_committee_description": "Gastroenterology, Urology",
      "address_1": "380 Elgin Mills Rd. E.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "KPO",
      "openfda": {
        "device_name": "Dialysate Concentrate For Hemodialysis (Liquid Or Powder)",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5820",
        "device_class": "2",
        "registration_number": [
          "3003464075",
          "9611823",
          "3027241826",
          "1528807",
          "3004176176",
          "1835498",
          "2431908",
          "1652176",
          "3003591774",
          "3038195011",
          "3027592507",
          "1056186",
          "3005578748",
          "3012364195",
          "3013546115",
          "1954315",
          "3010242164",
          "3035708507",
          "9616277",
          "8030639",
          "3019131",
          "3005162618",
          "9610270",
          "2029275",
          "3013764800",
          "9610725",
          "3007137482",
          "3003768032",
          "2183415",
          "3043014136",
          "1651896",
          "1225714",
          "3032828299",
          "3016096143"
        ],
        "fei_number": [
          "3003244997",
          "3003464075",
          "3002970979",
          "3027241826",
          "3004176176",
          "3003310249",
          "2431908",
          "1000142899",
          "3003591774",
          "3006475063",
          "3038195011",
          "3027592507",
          "3005578748",
          "3001451489",
          "3012364195",
          "3012394756",
          "3013546115",
          "3002807005",
          "1000306431",
          "1000132332",
          "3010242164",
          "3035708507",
          "3001236991",
          "6898",
          "3013942511",
          "3013764800",
          "3007137482",
          "2183415",
          "3043014136",
          "405",
          "3003463852",
          "1527681",
          "3032828299",
          "3016096143"
        ]
      },
      "zip_code": "L4C 5H2",
      "applicant": "Novex Pharma",
      "decision_date": "2000-06-30",
      "decision_code": "SESE",
      "country_code": "CA",
      "device_name": "NORMOCARB STERILE BICARBONATE RENAL DIALYSIS",
      "advisory_committee": "GU",
      "contact": "JOSSEPH W BEYGER",
      "expedited_review_flag": "",
      "k_number": "K001059",
      "state": "",
      "date_received": "2000-04-03",
      "review_advisory_committee": "GU",
      "postal_code": "L4C 5H2",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}