{
  "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": "Galway",
      "advisory_committee_description": "General, Plastic Surgery",
      "address_1": "Galway Harbour Enterprise Par, New Docks, The Docks",
      "address_2": "",
      "statement_or_summary": "",
      "product_code": "QML",
      "openfda": {
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        "device_name": "Anal Fistula Closure Device",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4835",
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      },
      "zip_code": "H91 NNY6",
      "applicant": "Signum Surgical Limited",
      "decision_date": "2024-07-01",
      "decision_code": "DENG",
      "country_code": "IE",
      "device_name": "BioHealx Anal Fistula Device",
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      "k_number": "DEN240007",
      "state": "",
      "date_received": "2024-02-02",
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      "postal_code": "H91 NNY6",
      "decision_description": "Unknown",
      "clearance_type": "Direct"
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}