{
  "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": "2026-10-26",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 33
    }
  },
  "results": [
    {
      "proprietary_name": [
        "SUCTION NIPPLE CLEANING ADAPTER (OE-C8)",
        "SUCTION VALVE REPLACES OF-B157 70K/80K (OF-B177)",
        "O-RING SET FOR THE OF-B178 A/W VALVE (OF-B184)",
        "AIR/WATER/SUCTION RUBBER CHANNEL CLEANING ADAPTER (OF-B166)",
        "AIR/WATER FEEDING VALVE FOR 70K/80K SERIES (OF-B183)",
        "VIDEO SIGMOIDOSCOPE (ES-3870K)"
      ],
      "establishment_type": [
        "Export Device to the United States But Perform No Other Operation on Device"
      ],
      "registration": {
        "registration_number": "3014605202",
        "fei_number": "3014605202",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "PENTAX MEDICAL (PENANG) SDN. BHD.",
        "address_line_1": "Plot 554, Lorong Perusahaan 4",
        "address_line_2": "Prai Free Trade Zone",
        "city": "Penang Pulau Pinang",
        "state_code": "",
        "iso_country_code": "MY",
        "zip_code": "",
        "postal_code": "13600",
        "us_agent": {
          "name": "Paresh Patel",
          "business_name": "HOYA CORPORATION PENTAX DIVISION",
          "bus_phone_area_code": "201",
          "bus_phone_num": "5712300",
          "bus_phone_extn": "2312",
          "fax_area_code": "201",
          "fax_num": "5712340",
          "email_address": "paresh.patel@pentaxmedical.com",
          "address_line_1": "3 Paragon Drive",
          "address_line_2": "",
          "city": "Montvale",
          "state_code": "NJ",
          "iso_country_code": "US",
          "zip_code": "07645",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "HOYA Corporation PENTAX Division",
          "owner_operator_number": "8030235",
          "official_correspondent": {
            "first_name": "Paresh",
            "middle_initial": "",
            "last_name": "Patel",
            "subaccount_company_name": "",
            "phone_number": "x-201-5712300-2312"
          },
          "contact_address": {
            "address_1": "3 Paragon Drive",
            "address_2": "",
            "city": "Montvale",
            "state_code": "NJ",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "07645"
          }
        }
      },
      "pma_number": "",
      "k_number": "K951577",
      "products": [
        {
          "product_code": "FAM",
          "created_date": "2009-06-05",
          "owner_operator_number": "8030235",
          "exempt": "",
          "openfda": {
            "device_name": "Sigmoidoscope And Accessories, Flexible/Rigid",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1500",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}