{
  "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": "2026-09-14",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Zunyi",
      "advisory_committee_description": "Neurology",
      "address_1": "2f&3f, Bldg. B, Phase 1, Guizhou Loushanguan High-Tech",
      "address_2": "Industrial Development Zone, Chumi Town, Tongzi County",
      "statement_or_summary": "Summary",
      "product_code": "HBF",
      "openfda": {
        "registration_number": [
          "3010596852",
          "3009732568",
          "1045834",
          "3014334038",
          "3015967359",
          "3007031059",
          "1828288",
          "3010370650",
          "9616696",
          "3003418325",
          "3014579161",
          "3012421607",
          "1526534",
          "3012494290",
          "3010173425",
          "2030624",
          "3010097171",
          "3040335671",
          "9681465",
          "3010726901",
          "3013557562",
          "3005562917",
          "1220477",
          "3010155648",
          "3014724561",
          "3030733800",
          "1058584",
          "3009417901",
          "1220724"
        ],
        "fei_number": [
          "3010596852",
          "3003164255",
          "3009732568",
          "1045834",
          "3014334038",
          "3015967359",
          "3007031059",
          "1828288",
          "1000219637",
          "3003418325",
          "3014579161",
          "3012421607",
          "1526534",
          "3012494290",
          "3010097171",
          "3040335671",
          "3010726901",
          "3000206435",
          "3002807036",
          "3013557562",
          "3005562917",
          "1220477",
          "3010155648",
          "3014724561",
          "3030733800",
          "3002807113",
          "3009417901",
          "1220724",
          "3010165944"
        ],
        "device_name": "Drills, Burrs, Trephines & Accessories (Compound, Powered)",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.4305",
        "device_class": "2"
      },
      "zip_code": "563200",
      "applicant": "Guizhou Zirui Technology Co., Ltd.",
      "decision_date": "2026-09-11",
      "decision_code": "SESE",
      "country_code": "CN",
      "device_name": "Disposable Sterile Skull Drill (LZ)",
      "advisory_committee": "NE",
      "contact": "Chang Feng  Liu",
      "expedited_review_flag": "",
      "k_number": "K254177",
      "state": "",
      "date_received": "2025-12-23",
      "review_advisory_committee": "NE",
      "postal_code": "563200",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}