{
  "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": "2026-07-27",
    "results": {
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  "results": [
    {
      "third_party_flag": "N",
      "city": "San Jose",
      "advisory_committee_description": "General, Plastic Surgery",
      "address_1": "3047 Orchard Pkwy.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "PQN",
      "openfda": {
        "registration_number": [
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        "fei_number": [
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        "device_name": "Carbon Dioxide Gas Controlled Tissue Expander",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.3510",
        "device_class": "2"
      },
      "zip_code": "95134",
      "applicant": "Airxpanders, Inc.",
      "decision_date": "2019-07-11",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "AeroForm Tissue Expander, Smooth",
      "advisory_committee": "SU",
      "contact": "Belinda  Pinedo",
      "expedited_review_flag": "",
      "k_number": "K191138",
      "state": "CA",
      "date_received": "2019-04-30",
      "review_advisory_committee": "SU",
      "postal_code": "95134",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Special"
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}