{
  "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": "2026-07-20",
    "results": {
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  "results": [
    {
      "third_party_flag": "N",
      "city": "Oradell",
      "advisory_committee_description": "Gastroenterology, Urology",
      "address_1": "690 Kinderkamack Rd., 1st Floor",
      "address_2": "P.O. Box 637",
      "statement_or_summary": "Summary",
      "product_code": "FAP",
      "openfda": {
        "device_name": "Cystometric Gas (Carbon-Dioxide) On Hydraulic Device",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1620",
        "device_class": "2",
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          "3006849754",
          "1820334",
          "3011534533",
          "1825146",
          "3004365956",
          "3011137372",
          "2132111",
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      },
      "zip_code": "07649",
      "applicant": "F.M. Wiest USA, Inc.",
      "decision_date": "1992-07-23",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "MERKUR 4000",
      "advisory_committee": "GU",
      "contact": "GEORGE  BATHELOR",
      "expedited_review_flag": "",
      "k_number": "K920575",
      "state": "NJ",
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      "postal_code": "07649",
      "decision_description": "Substantially Equivalent",
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}