{
  "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": "2026-06-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Needham",
      "advisory_committee_description": "Ear, Nose, Throat",
      "address_1": "250 First Ave., Suite 205",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "NHB",
      "openfda": {
        "device_name": "Polymer, Ear, Nose And Throat, Synthetic, Absorbable",
        "medical_specialty_description": "Ear, Nose, Throat",
        "regulation_number": "874.3620",
        "device_class": "2",
        "registration_number": [
          "3005465238",
          "1058584",
          "3022140316",
          "3007162658",
          "3017102971",
          "1213643",
          "3007225047",
          "1450662",
          "3015967359",
          "1825034",
          "3006345872",
          "1061124",
          "1811755",
          "3030653921",
          "1423662",
          "3011088743",
          "3008791915",
          "1223089",
          "3002294946",
          "2029275",
          "1424263",
          "1220477",
          "2183967",
          "3043562110",
          "3005941719",
          "3009736544",
          "2032098",
          "2183319",
          "3012448339",
          "3015528146",
          "2210968",
          "3012263097",
          "3004681519",
          "2953359",
          "3040335671",
          "3005689226",
          "3017210488"
        ],
        "fei_number": [
          "3005465238",
          "3022140316",
          "3007162658",
          "3000215205",
          "3017102971",
          "1213643",
          "1000120505",
          "3007225047",
          "1450662",
          "1000219637",
          "3015967359",
          "3002807111",
          "1000306431",
          "1825034",
          "3006345872",
          "3000215273",
          "1811755",
          "3030653921",
          "3011088743",
          "3008791915",
          "3003870583",
          "3002294946",
          "1000115735",
          "1220477",
          "3043562110",
          "3009736544",
          "3003058448",
          "2183319",
          "3012448339",
          "3015528146",
          "2210968",
          "3012263097",
          "1000512168",
          "3003015552",
          "3040335671",
          "3005689226",
          "3017210488"
        ]
      },
      "zip_code": "02494",
      "applicant": "3-D Matrix, Inc.",
      "decision_date": "2019-04-12",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "PuraSinus",
      "advisory_committee": "EN",
      "contact": "Lisa  Spirio",
      "expedited_review_flag": "",
      "k_number": "K183015",
      "state": "MA",
      "date_received": "2018-10-31",
      "review_advisory_committee": "EN",
      "postal_code": "02494",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}