{
  "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": 7
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Dallas",
      "advisory_committee_description": "General, Plastic Surgery",
      "address_1": "10925 Estate Ln., Suite W-185",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "PMC",
      "openfda": {
        "device_name": "Scalp Cooling System",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4360",
        "device_class": "2",
        "registration_number": [
          "3008938259",
          "3008888703",
          "3012187635",
          "3021619527",
          "3012146457",
          "3044829899",
          "1648700"
        ],
        "fei_number": [
          "3000204260",
          "3008938259",
          "3008888703",
          "3012187635",
          "3021619527",
          "3012146457",
          "3044829899"
        ]
      },
      "zip_code": "75238",
      "applicant": "Dignitana, Inc.",
      "decision_date": "2019-06-26",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "DigniCap Delta",
      "advisory_committee": "SU",
      "contact": "William  Cronin",
      "expedited_review_flag": "",
      "k_number": "K191166",
      "state": "TX",
      "date_received": "2019-05-01",
      "review_advisory_committee": "SU",
      "postal_code": "75238",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}