{
  "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": {
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  "results": [
    {
      "third_party_flag": "N",
      "city": "El Dorado Hills",
      "advisory_committee_description": "General Hospital",
      "address_1": "1264 Hawks Flight Ct., Suite 200",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "PKP",
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        "device_name": "Immunoglobulin G (Igg) Infusion System",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5725",
        "device_class": "2"
      },
      "zip_code": "95762",
      "applicant": "Emed Technologies Corporation",
      "decision_date": "2016-12-01",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "SCIg60 Infuser",
      "advisory_committee": "HO",
      "contact": "PETER  KOLLINGS",
      "expedited_review_flag": "",
      "k_number": "K161906",
      "state": "CA",
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      "postal_code": "95762",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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}