{
  "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": 3
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Flexible Overtube"
      ],
      "establishment_type": [
        "Sterilize Medical Device for Another Party (Contract Sterilizer)",
        "Manufacture Medical Device for Another Party (Contract Manufacturer)"
      ],
      "registration": {
        "registration_number": "3010141954",
        "fei_number": "3010141954",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "Sumitomo Bakelite (Dongguan) Co., Ltd.",
        "address_line_1": "No. 2 Qiaolin Road Lingtou Industrial District, Qiaotou Town",
        "address_line_2": "",
        "city": "Dongguan Guangdong",
        "state_code": "",
        "iso_country_code": "CN",
        "zip_code": "",
        "postal_code": "523530",
        "us_agent": {
          "name": "Takahito Ishikawa",
          "business_name": "Sumitomo Plastics America, Inc.",
          "bus_phone_area_code": "408",
          "bus_phone_num": "3355883",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "t_ishikawa@sumibe.co.jp",
          "address_line_1": "4675 Stevens Creek Blvd Ste 101",
          "address_line_2": "",
          "city": "Santa Clara",
          "state_code": "CA",
          "iso_country_code": "US",
          "zip_code": "95051",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "SB-KAWASUMI LABORATORIES, INC.",
          "owner_operator_number": "8031539",
          "official_correspondent": {
            "first_name": "Kenichi",
            "middle_initial": "-",
            "last_name": "Inamura",
            "subaccount_company_name": "",
            "phone_number": "81-44-5899750-x"
          },
          "contact_address": {
            "address_1": "3-25-4 Tonomachi",
            "address_2": "Kawasaki-ku",
            "city": "Kawasaki-shi",
            "state_code": "JP-14",
            "state_province": "Kanagawa",
            "iso_country_code": "JP",
            "postal_code": "210-8602"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "FED",
          "created_date": "2021-12-16",
          "owner_operator_number": "8031539",
          "exempt": "",
          "openfda": {
            "device_name": "Endoscopic Access Overtube, Gastroenterology-Urology",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1500",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}