{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Lund",
      "advisory_committee_description": "General, Plastic Surgery",
      "address_1": "Traktorgranden 3",
      "address_2": "",
      "statement_or_summary": "",
      "product_code": "PMC",
      "openfda": {
        "registration_number": [
          "3012146457",
          "3021619527",
          "3008938259",
          "3008888703",
          "3044829899",
          "3012187635",
          "1648700"
        ],
        "fei_number": [
          "3012146457",
          "3021619527",
          "3008938259",
          "3008888703",
          "3044829899",
          "3000204260",
          "3012187635"
        ],
        "device_name": "Scalp Cooling System",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4360",
        "device_class": "2"
      },
      "zip_code": "se-226 60",
      "applicant": "Dignitana AB",
      "decision_date": "2015-12-08",
      "decision_code": "DENG",
      "country_code": "SE",
      "device_name": "Dignitana AB DigniCap System",
      "advisory_committee": "SU",
      "contact": "JAN  RICHARDSSON",
      "expedited_review_flag": "",
      "k_number": "DEN150010",
      "state": "",
      "date_received": "2015-03-06",
      "review_advisory_committee": "SU",
      "postal_code": "se-226 60",
      "decision_description": "Unknown",
      "clearance_type": "Direct"
    }
  ]
}