{
  "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": "West Lafayette",
      "advisory_committee_description": "General, Plastic Surgery",
      "address_1": "1425 Innovation Pl.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "OXN",
      "openfda": {
        "registration_number": [
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          "1835959"
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        "fei_number": [
          "1000393132",
          "3002340648"
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        "device_name": "Mesh, Surgical, Collagen, Fistula",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.3300",
        "device_class": "2"
      },
      "zip_code": "47906",
      "applicant": "Cook Biotech Incorporated",
      "decision_date": "2019-12-27",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft",
      "advisory_committee": "SU",
      "contact": "Perry W. Guinn",
      "expedited_review_flag": "",
      "k_number": "K191696",
      "state": "IN",
      "date_received": "2019-06-25",
      "review_advisory_committee": "SU",
      "postal_code": "47906",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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  ]
}