{
  "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": "2026-09-21",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Edmonton",
      "advisory_committee_description": "General, Plastic Surgery",
      "address_1": "200, 2003-91 St. SW",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "QSO",
      "openfda": {
        "device_name": "Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4040",
        "device_class": "2",
        "registration_number": [
          "3017171460",
          "1417592",
          "3003561450",
          "9681151",
          "3012344767",
          "3011545608"
        ],
        "fei_number": [
          "3017171460",
          "1417592",
          "3003792528",
          "3003561450",
          "3012344767",
          "3011545608"
        ]
      },
      "zip_code": "T6X 0W8",
      "applicant": "PRIMED Medical Products, Inc.",
      "decision_date": "2026-09-01",
      "decision_code": "SESE",
      "country_code": "CA",
      "device_name": "PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3)",
      "advisory_committee": "SU",
      "contact": "Mitra  Fard",
      "expedited_review_flag": "",
      "k_number": "K261811",
      "state": "",
      "date_received": "2026-06-01",
      "review_advisory_committee": "HO",
      "postal_code": "T6X 0W8",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}