{
  "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": "Newton",
      "advisory_committee_description": "Gastroenterology, Urology",
      "address_1": "One Newton Executive Park, Suite 102",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "PLQ",
      "openfda": {
        "device_name": "Enzyme Packed Cartridge",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5985",
        "device_class": "2",
        "registration_number": [
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          "3009596666"
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      "applicant": "Alcresta Therapeutics, Inc.",
      "decision_date": "2016-06-30",
      "decision_code": "SESE",
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      "device_name": "Relizorb",
      "advisory_committee": "GU",
      "contact": "Robert  Gallotto",
      "expedited_review_flag": "",
      "k_number": "K161247",
      "state": "MA",
      "date_received": "2016-05-03",
      "review_advisory_committee": "GU",
      "postal_code": "02462",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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  ]
}