{
  "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": "2026-04-13",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "third_party_flag": "N",
      "city": "Carpinteria",
      "advisory_committee_description": "Ear, Nose, Throat",
      "address_1": "1110 Mark Ave.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "EWL",
      "openfda": {
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          "3013188547",
          "2011171",
          "2025182",
          "2029275"
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          "3002806269",
          "2011171",
          "2025182"
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        "device_name": "Prosthesis, Laryngeal (Taub)",
        "medical_specialty_description": "Ear, Nose, Throat",
        "regulation_number": "874.3730",
        "device_class": "2"
      },
      "zip_code": "93013",
      "applicant": "Helix Medical, LLC",
      "decision_date": "2008-09-04",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES",
      "advisory_committee": "EN",
      "contact": "CYNTHIA  ANDERSON",
      "expedited_review_flag": "",
      "k_number": "K082206",
      "state": "CA",
      "date_received": "2008-08-05",
      "review_advisory_committee": "EN",
      "postal_code": "93013",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Special"
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}