{
  "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": "2026-06-01",
    "results": {
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    {
      "third_party_flag": "N",
      "city": "Armagh Bt66 8rd",
      "advisory_committee_description": "Gastroenterology, Urology",
      "address_1": "Portadown Rd., Lurgan,",
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      "statement_or_summary": "",
      "product_code": "FAP",
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          "1825146",
          "1820334",
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        "device_name": "Cystometric Gas (Carbon-Dioxide) On Hydraulic Device",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1620",
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      },
      "zip_code": "",
      "applicant": "Warne Surgical Products, Ltd.",
      "decision_date": "1985-05-16",
      "decision_code": "SESE",
      "country_code": "IE",
      "device_name": "WSP CODE 4301 DIOMASTER THERAPEUTIC",
      "advisory_committee": "GU",
      "contact": "LEWIS  HAMILTON",
      "expedited_review_flag": "",
      "k_number": "K850695",
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      "date_received": "1985-02-21",
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      "postal_code": "",
      "decision_description": "Substantially Equivalent",
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