{
  "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": "2026-04-13",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Suzhou",
      "advisory_committee_description": "Gastroenterology, Urology",
      "address_1": "#2, Qingqiu St., Suzhou Industrial Park,",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "FBN",
      "openfda": {
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        "regulation_number": "876.1500",
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      "zip_code": "215000",
      "applicant": "Scivita Medical Technology Co., Ltd.",
      "decision_date": "2026-01-20",
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      "country_code": "CN",
      "device_name": "Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)",
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      "contact": "Wu  Ruqin",
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      "k_number": "K251338",
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      "date_received": "2025-04-30",
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      "decision_description": "Substantially Equivalent",
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}