{
  "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,
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  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Lake Zurich",
      "advisory_committee_description": "Unknown",
      "address_1": "Three Corporate Dr.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "LKN",
      "openfda": {
        "device_name": "Separator, Automated, Blood Cell And Plasma, Therapeutic",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "U",
        "registration_number": [
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      },
      "zip_code": "60047",
      "applicant": "Fresenius Kabi USA,Llc",
      "decision_date": "2018-12-04",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter",
      "advisory_committee": "",
      "contact": "Kim  Forch",
      "expedited_review_flag": "",
      "k_number": "K180615",
      "state": "IL",
      "date_received": "2018-03-08",
      "review_advisory_committee": "GU",
      "postal_code": "60047",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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}