{
  "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": "2026-09-07",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "proprietary_name": [
        "ADAPT Tissue"
      ],
      "establishment_type": [
        "Manufacture Medical Device for Another Party (Contract Manufacturer)",
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3010805634",
        "fei_number": "3010805634",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "Anteris Aus Operations Pty Ltd",
        "address_line_1": "26 Harris Road",
        "address_line_2": "",
        "city": "Malaga Western Australia",
        "state_code": "",
        "iso_country_code": "AU",
        "zip_code": "",
        "postal_code": "6090",
        "us_agent": {
          "name": "Renee Cveykus",
          "business_name": "Anteris Technologies Corporation",
          "bus_phone_area_code": "651",
          "bus_phone_num": "4930606",
          "bus_phone_extn": "",
          "fax_area_code": "651",
          "fax_num": "5288042",
          "email_address": "rcveykus@anteristech.com",
          "address_line_1": "860 Blue Gentian Rd",
          "address_line_2": "",
          "city": "Eagan",
          "state_code": "MN",
          "iso_country_code": "US",
          "zip_code": "55121",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Anteris Technology Corporation",
          "owner_operator_number": "10046278",
          "official_correspondent": {
            "first_name": "Renee",
            "middle_initial": "",
            "last_name": "Cveykus",
            "subaccount_company_name": "",
            "phone_number": "001-651-3221641-x"
          },
          "contact_address": {
            "address_1": "860 Blue Gentian Road",
            "address_2": "Suite 340",
            "city": "Eagan",
            "state_code": "MN",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "55121"
          }
        }
      },
      "pma_number": "",
      "k_number": "K200566",
      "products": [
        {
          "product_code": "PSQ",
          "created_date": "2020-06-09",
          "owner_operator_number": "10046278",
          "exempt": "",
          "openfda": {
            "k_number": [
              "K200566"
            ],
            "device_name": "Intracardiac Patch Or Pledget, Biologically Derived",
            "medical_specialty_description": "Cardiovascular",
            "regulation_number": "870.3470",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}