{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Miami Lakes",
      "advisory_committee_description": "General, Plastic Surgery",
      "address_1": "14175 NW 60th Ave.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "NBY",
      "openfda": {
        "registration_number": [
          "1647149",
          "3010692967",
          "3012421607",
          "3016443334",
          "3013354263",
          "2531321",
          "3012101664",
          "3017399129",
          "3008879776",
          "1061927",
          "1066741",
          "3012494290",
          "3014117096",
          "1416605",
          "1650372",
          "3014448321",
          "3014579161",
          "3006981798",
          "3005953126",
          "2030624",
          "1320468",
          "1226146",
          "2246552",
          "3011560638",
          "3029901632",
          "3004361903",
          "3015489699",
          "3011276344",
          "3004431266",
          "3006562124",
          "1064584",
          "3014606366",
          "3010860245"
        ],
        "fei_number": [
          "3000206455",
          "3010692967",
          "3000206435",
          "3012421607",
          "3016443334",
          "3013354263",
          "3012101664",
          "3017399129",
          "3008879776",
          "3012494290",
          "3014117096",
          "1416605",
          "3001237758",
          "3014448321",
          "3014579161",
          "3003005156",
          "3006981798",
          "3005953126",
          "3003063934",
          "2246552",
          "3011560638",
          "3029901632",
          "3004361903",
          "3015489699",
          "3011276344",
          "3004431266",
          "3006562124",
          "3002253367",
          "3000203000",
          "1000306139",
          "3014606366",
          "3002680121",
          "3010860245"
        ],
        "device_name": "Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.5035",
        "device_class": "2"
      },
      "zip_code": "33104",
      "applicant": "Demetech Corporation",
      "decision_date": "2018-10-11",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "DemeTECH PTFE Nonabsorbable Surgical Suture",
      "advisory_committee": "SU",
      "contact": "Linda  Hernandez",
      "expedited_review_flag": "",
      "k_number": "K181578",
      "state": "FL",
      "date_received": "2018-06-15",
      "review_advisory_committee": "SU",
      "postal_code": "33104",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}