{
  "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": {
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  "results": [
    {
      "third_party_flag": "N",
      "city": "Scotland",
      "advisory_committee_description": "Gastroenterology, Urology",
      "address_1": "Bridgend Rd. Industrial Estate",
      "address_2": "Dingwall, Ross-Shire Iv15 9qf",
      "statement_or_summary": "Statement",
      "product_code": "FAP",
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        "device_name": "Cystometric Gas (Carbon-Dioxide) On Hydraulic Device",
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          "1820334",
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      "applicant": "Aspen Medical , Ltd.",
      "decision_date": "1992-06-02",
      "decision_code": "SESE",
      "country_code": "GB",
      "device_name": "PHOENIX 5 URODYNAMICS SYSTEM",
      "advisory_committee": "GU",
      "contact": "ROSS K MAXWELL",
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      "k_number": "K914300",
      "state": "",
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      "decision_description": "Substantially Equivalent",
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}