{
  "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": "Alexandria",
      "advisory_committee_description": "General, Plastic Surgery",
      "address_1": "901 King St., Suite 200",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "OTK",
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        "device_name": "Wound Drain Catheter System",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4780",
        "device_class": "2"
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      "zip_code": "22314",
      "applicant": "Clear Catheter Systems",
      "decision_date": "2010-12-03",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "PLEURAFLOW CATHETER SYSTEM",
      "advisory_committee": "SU",
      "contact": "MONICA  DOUGHERTY",
      "expedited_review_flag": "",
      "k_number": "K093565",
      "state": "VA",
      "date_received": "2009-11-18",
      "review_advisory_committee": "SU",
      "postal_code": "22314",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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}